FDA QMSR / 21 CFR Part 820 transition to ISO 13485 * ISO 13485 Quality Management Systems * Certified Lead Auditor or equivalent auditing certification. * Experience interacting with regulatory ...
FDA QMSR / 21 CFR Part 820 transition to ISO 13485 * ISO 13485 Quality Management Systems * Certified Lead Auditor or equivalent auditing certification. * Experience interacting with regulatory ...
FDA QMSR / 21 CFR Part 820 transition to ISO 13485 * ISO 13485 Quality Management Systems * Certified Lead Auditor or equivalent auditing certification. * Experience interacting with regulatory ...
FDA QMSR / 21 CFR Part 820 transition to ISO 13485 * ISO 13485 Quality Management Systems * Certified Lead Auditor or equivalent auditing certification. * Experience interacting with regulatory ...
... Auditing & Inspection Readiness * Participate in internal and external audits, serving as a subject matter expert * Support preparation for FDA and customer inspections * Monitor and follow up on ...
... Auditing & Inspection Readiness * Participate in internal and external audits, serving as a subject matter expert * Support preparation for FDA and customer inspections * Monitor and follow up on ...
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $70K/yr
... Auditing & Inspection Readiness * Participate in internal and external audits, serving as a subject matter expert * Support preparation for FDA and customer inspections * Monitor and follow up on ...
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $70K/yr
... Auditing & Inspection Readiness * Participate in internal and external audits, serving as a subject matter expert * Support preparation for FDA and customer inspections * Monitor and follow up on ...
... FDA 21 CFR 820) Preferred: · ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical Writing · Understanding and familiarity with design history files, change management ...
... FDA 21 CFR 820) Preferred: · ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical Writing · Understanding and familiarity with design history files, change management ...
QMS Manager
$115K - $135K/yr
Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820) Preferred * ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical ...
QMS Manager
$115K - $135K/yr
Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820) Preferred * ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical ...
... FDA 21 CFR 820, ISO 13485). * Partner with customers to complete qualification activities for ... Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct ...
... FDA 21 CFR 820, ISO 13485). * Partner with customers to complete qualification activities for ... Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct ...
... FDA 21 CFR 820, ISO 13485). * Partner with customers to complete qualification activities for ... Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct ...
... FDA 21 CFR 820, ISO 13485). * Partner with customers to complete qualification activities for ... Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct ...
Sample Login Technician
$19.50/hr
EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...
Quick apply
Sample Login Technician
$19.50/hr
EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...
Quality Assurance Representative
Denver, CO · On-site
$62K - $67K/yr
Knowledge of quality auditing, inspection methods * Detail oriented * Strong organizational skills ... Knowledge of FDA regulations Language / Communication Skills: * Excellent oral and written ...
Quality Assurance Representative
Denver, CO · On-site
$62K - $67K/yr
Knowledge of quality auditing, inspection methods * Detail oriented * Strong organizational skills ... Knowledge of FDA regulations Language / Communication Skills: * Excellent oral and written ...
Quality Assurance Representative
Denver, CO · On-site
$62K - $67K/yr
Knowledge of quality auditing, inspection methods * Detail oriented * Strong organizational skills ... Knowledge of FDA regulations Language / Communication Skills: * Excellent oral and written ...
Quality Assurance Representative
Denver, CO · On-site
$62K - $67K/yr
Knowledge of quality auditing, inspection methods * Detail oriented * Strong organizational skills ... Knowledge of FDA regulations Language / Communication Skills: * Excellent oral and written ...
Assistant General Manager
Denver, CO · On-site
$140K - $150K/yr
FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...
Assistant General Manager
Denver, CO · On-site
$140K - $150K/yr
FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...
Demonstrated familiarity with/experience of with internal or external auditing * Experience in ... FDA), CC (MHRA; FDA) * Previous experience in GMP production sites * Understanding regulatory ...
Demonstrated familiarity with/experience of with internal or external auditing * Experience in ... FDA), CC (MHRA; FDA) * Previous experience in GMP production sites * Understanding regulatory ...
Quality Assurance Training Assistant
Denver, CO · On-site
$23 - $26/hr
Belmar Select Outsourcing is an FDA registered 503B Outsourcing Facility with a location in ... Auditing of new hire training to ensure all required documentation has been completed. * Tracking ...
Quality Assurance Training Assistant
Denver, CO · On-site
$23 - $26/hr
Belmar Select Outsourcing is an FDA registered 503B Outsourcing Facility with a location in ... Auditing of new hire training to ensure all required documentation has been completed. * Tracking ...
Assistant General Manager
$140K - $150K/yr
FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...
Assistant General Manager
$140K - $150K/yr
FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...
Sample Login Technician
Greeley, CO · On-site
$19.50/hr
EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...
Sample Login Technician
Greeley, CO · On-site
$19.50/hr
EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...
CAPA Specialist
Englewood, CO · On-site
$60K - $75K/yr
A strong background in QMS auditing and compliance tracking. * Exceptional problem-solving skills ... Ensure continued compliance of work to QMS requirements per FDA QSR, European MDD/MDR, ISO 13485 ...
CAPA Specialist
Englewood, CO · On-site
$60K - $75K/yr
A strong background in QMS auditing and compliance tracking. * Exceptional problem-solving skills ... Ensure continued compliance of work to QMS requirements per FDA QSR, European MDD/MDR, ISO 13485 ...
Working knowledge of global regulatory requirements, including FDA, EU MDR, Health Canada, and ... Experience interacting with regulatory authorities, notified bodies, or internal auditors * Project ...
Working knowledge of global regulatory requirements, including FDA, EU MDR, Health Canada, and ... Experience interacting with regulatory authorities, notified bodies, or internal auditors * Project ...
... auditing requirements have been completed prior to the start of a study. * Will produce, as ... Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. * Excellent ...
... auditing requirements have been completed prior to the start of a study. * Will produce, as ... Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. * Excellent ...
Director of Quality
Grand Junction, CO · On-site
Knowledge of quality systems and standards relevant to Medical, Energy, and Automotive industries (e.g., ISO, IATF, FDA, etc.). Preferred Certifications: * ASQ * Lead Auditor Functional/Technical ...
Director of Quality
Grand Junction, CO · On-site
Knowledge of quality systems and standards relevant to Medical, Energy, and Automotive industries (e.g., ISO, IATF, FDA, etc.). Preferred Certifications: * ASQ * Lead Auditor Functional/Technical ...
Fda Auditor information
See Colorado salary details
$34.7K - $43.2K
2% of jobs
$43.2K - $51.6K
17% of jobs
$56K is the 25th percentile. Wages below this are outliers.
$51.6K - $60.1K
12% of jobs
$60.1K - $68.5K
11% of jobs
The median wage is $73K / yr.
$68.5K - $77K
17% of jobs
$77K - $85.5K
7% of jobs
$85.5K - $93.9K
6% of jobs
$93.9K - $102.4K
3% of jobs
$102.5K is the 75th percentile. Wages above this are outliers.
$102.4K - $110.8K
17% of jobs
$110.8K - $119.3K
4% of jobs
$119.3K - $127.8K
4% of jobs
$34.7K
$80.2K
$127.8K
How much do fda auditor jobs pay per year?
What is an FDA auditor?
An FDA Auditor is responsible for inspecting facilities, processes, and documentation to ensure compliance with U.S. Food and Drug Administration (FDA) regulations. They review manufacturing practices, quality control systems, and regulatory filings for industries such as pharmaceuticals, medical devices, and food production. FDA Auditors may work for the FDA or for companies preparing for FDA inspections. Their role helps ensure public safety by verifying that products meet legal and quality standards.
What are the key skills and qualifications needed to thrive as an FDA auditor?
To thrive as an FDA Auditor, you need a strong background in life sciences, regulatory compliance, and audit methodologies, usually supported by a relevant degree and professional certifications such as RAC or CQA. Familiarity with FDA regulations (such as 21 CFR), electronic quality management systems (eQMS), and audit management tools is essential. Attention to detail, critical thinking, and strong communication skills help auditors navigate complex regulatory settings and interact effectively with stakeholders. These competencies are crucial for ensuring companies meet rigorous FDA standards and maintain regulatory compliance.
What do FDA auditors make?
How to become an FDA auditor?
What are the primary challenges FDA auditors face during compliance inspections?
FDA Auditors often encounter challenges such as interpreting complex and evolving regulatory guidelines, managing on-site audits in diverse environments, and reviewing extensive documentation under tight timeframes. They must adapt quickly to various industry settings, handle potentially uncooperative stakeholders, and maintain objectivity throughout their evaluations. Successfully overcoming these challenges requires resilience, up-to-date regulatory knowledge, and excellent people skills. These hurdles are a vital part of ensuring public health and safety by holding organizations to the highest standards of compliance.
What are the most commonly searched types of Fda Auditor jobs in Colorado?
The most popular types of Fda Auditor jobs in Colorado are:
What are popular job titles related to Fda Auditor jobs in Colorado?
For Fda Auditor jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Fda Auditor jobs in Colorado look for?
The top searched job categories for Fda Auditor jobs in Colorado are:
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- Gcp Quality Assurance
- Internship Gmp Quality Assurance
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 8 days ago
Medtronic rating
7.9
Based on 176 frontline employees who took The Breakroom Quiz
161st of 540 rated manufacturers
Job description
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the LifeBusiness Group: Global Quality / Enterprise Quality
Location: Flexible (U.S. or Global Medtronic Location)
The Senior Manager, Compliance & Internal Auditis responsible forleading and advancing Medtronic's globalinternalaudit program to ensure compliance with applicable regulatory requirements and quality management standards. This role provides strategic leadership for internal audits aligned with the Medical Device Single Audit Program (MDSAP), FDA Quality Management System Regulation (QMSR), ISO 13485, and other applicable global regulatory frameworks.
The Senior Manager will partnercrossfunctionallywith Quality, Regulatory Affairs, Operations, R&D, and functional leadership to assess enterprise compliance,identifysystemic risks, and strengthen the effectiveness of the Medtronic Quality Management System. This role plays a keypartin driving inspection readiness and supporting continuous improvement across the enterprise.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Key Responsibilities
Internal Audit Program Leadership
Lead and manage enterprise internal audit activities aligned with global regulatory requirements including MDSAP, QMSR, and ISO 13485.
Develop and executeriskbasedauditschedule, auditplans across Medtronic operating units, manufacturing sites, andenterprisefunctions.
Serve as Lead Auditor for complex orhighimpactcompliance audits.
Ensure audits are conductedin accordance withinternal procedures, regulatory expectations, and recognized auditing standards.
Regulatory Compliance & Risk Oversight
Provide subject matterexpertiseon regulatory quality requirements and global compliance expectations.
Evaluate the effectiveness and maturity of quality system processes across the organization.
Identify systemic compliance risks and provide recommendations for mitigation.
Inspection and Audit Readiness
Support enterprise preparation for regulatory inspections and external audits.
Leadand/orparticipateinmock inspections and readiness assessments to strengthen organizational preparedness.
Partner with site leadership to address compliance gaps and ensure sustainable remediation.
Corrective Action & Compliance Monitoring
Review audit findings and ensureappropriate rootcause analysis and corrective actions.
Monitor effectiveness of CAPA activities related tointernalaudit observations.
Track compliance trends and escalate systemic risks to leadership asappropriate.
Stakeholder Engagement
Collaborate with global stakeholders including Quality, Regulatory Affairs, Manufacturing, Supply Chain, and R&D.
Communicate audit results, risk assessments, and improvement opportunities to senior leadershipas per defined intervals andin management reviews.
Provide guidance on interpretation of regulatory requirements and quality system expectations.
Continuous Improvement
Identifyenterprise trends and opportunities for quality system improvement based on audit data.
Enhance audit methodologies, tools, and analytics capabilities.
Contribute to strengthening a proactive culture of compliance and quality.
Leadership & Talent Development
Mentor and develop internal auditors andcrossfunctionalaudit team members.
Provide training and coaching on regulatory audit techniques and compliance practices.
Minimum Qualifications
Bachelor's degree plus 7+ years of experience in quality, regulatory affairs, compliance, or related functions in the medical device or regulated healthcare industry.
Minimum3years of experience conducting or managing internal or regulatory audits.
Minimum 5 years ofmanagerialexperience
Demonstratedexpertisein:
MDSAP audit model
FDA QMSR / 21 CFR Part 820 transition to ISO 13485
ISO 13485 Quality Management Systems
Certified Lead Auditor or equivalent auditing certification.
Experience interacting with regulatory agencies or supporting regulatory inspections.
Preferred Qualifications
Bachelor's degree in engineering, Life Sciences, Quality, Regulatory Affairs, or related field.Advanced degree (MS, MBA, or related field).
Experience with global regulatory frameworks including EU MDR, Health Canada, PMDA, TGA, and ANVISA.
MDSAP auditing experience.
ASQ certifications (CQA, CQE, or equivalent).
Experience leadingenterpriselevelcompliance or audit programs.
Leadership Competencies (Medtronic Leadership Expectations)
Strategic mindset with the ability to assessenterpriselevelcompliance risks.
Strong stakeholder engagement and influencing skills across global organizations.
Ability to translate regulatory requirements into practical operational improvements.
Datadrivendecision making and risk management.
Commitment to developing talent and building strong audit capabilities.
Travel Requirements
Ability to traveldomestically andinternationally up to10-20% to Medtronic sites.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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