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Professional Qms Implementation Jobs in Michigan

Schupan

QMS Technician 2

Kalamazoo, MI · On-site

$17 - $23/hr

... implementation of cost-saving measures and continuous improvement activities * Assist and/or ... Ability to read, analyze, and interpret general business periodicals, professional journals ...

SCHUPAN & SONS INC

QMS Technician 2

Kalamazoo, MI

$17 - $23/hr

... implementation of cost-saving measures and continuous improvement activities * Assist and/or ... Ability to read, analyze, and interpret general business periodicals, professional journals ...

360 IT Professionals

SQA Engineer

Southfield, MI · On-site

Company Description 360 IT Professionals is a Software Development Company based in Fremont ... QMS to customer team Driving process implementation along with customer's Quality Assurance ...

Sbdinc

Quality Manager

Chesterfield, MI

Join our top-notch team of more than 50,000 diverse and high-performing professionals globally who ... The Quality Manager is responsible for overseeing and implementing quality control procedures ...

New

Graco

Factory Manager

Dexter, MI · On-site

Implement and audit QMS, utilizing quality management techniques for problem-solving and corrective ... Strong potential for career advancement and professional development. Applicants must be legally ...

Graco, Inc.

Factory Manager

Dexter, MI · On-site

... • Implement and audit QMS, utilizing quality management techniques for problem-solving and ... and professional development. Applicants must be legally authorized to work in the United States.

Quala

Quality and HSE Coordinator

Chesterfield, MI · On-site

$65K - $75K/yr

Implement process improvements, practice lean daily management principles, and actively support ... Oversee QMS to ensure compliance with ISO 9001:2015 standards and customer-specific requirements.

Quala

Quality and HSE Coordinator

Chesterfield, MI · On-site

$65K - $75K/yr

Implement process improvements, practice lean daily management principles, and actively support ... Oversee QMS to ensure compliance with ISO 9001:2015 standards and customer-specific requirements.

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All JobsProfessional Qms Implementation JobsProfessional Qms Implementation Jobs in Michigan

Professional Qms Implementation information

How to start implementing a QMS?

A Professional QMS Implementation begins with understanding the organization's processes and defining quality objectives. Next, develop a plan that includes process mapping, documentation, and training, while selecting appropriate tools and standards such as ISO 9001. Regular audits and continuous improvement ensure the system's effectiveness and compliance.

What is a Professional QMS Implementation?

A Professional QMS (Quality Management System) Implementation refers to the process of systematically establishing and integrating quality management practices within an organization, typically aligned with recognized standards like ISO 9001. Professionals in this role analyze current processes, identify gaps, develop policies and procedures, train staff, and ensure continuous improvement to meet quality objectives. The goal is to enhance product or service quality, improve customer satisfaction, and ensure regulatory compliance. Successful implementation often involves change management, documentation, and ongoing monitoring to sustain quality outcomes.

What is the salary for a quality manager?

The salary for a quality manager typically ranges from $70,000 to $120,000 annually, depending on experience, industry, and location. Certified quality management professionals with skills in ISO standards and process improvement often earn higher salaries.

What are the key skills and qualifications needed to thrive as a Professional QMS (Quality Management System) Implementation Specialist, and why are they important?

To excel as a Professional QMS Implementation Specialist, you need a strong understanding of quality management principles, relevant industry standards (such as ISO 9001), and often a bachelor's degree in a related field. Familiarity with QMS software platforms, documentation systems, and certifications like ISO 9001 Lead Auditor are commonly required. Excellent project management, problem-solving, and communication skills set standout professionals apart in this role. These competencies are vital for ensuring effective system rollout, regulatory compliance, and continuous organizational improvement.

What does a QMS specialist do?

A QMS specialist is responsible for developing, implementing, and maintaining a Quality Management System within an organization. They ensure compliance with industry standards, conduct audits, analyze data for process improvements, and often use tools like ISO standards and quality management software to support quality initiatives.

What do you mean by QMS implementation?

QMS implementation refers to the process of establishing and integrating a Quality Management System within an organization, such as ISO 9001. It involves developing procedures, training staff, and ensuring compliance to improve quality and operational efficiency.

What is the difference between Professional Qms Implementation vs Quality Assurance Specialist?

AspectProfessional Qms ImplementationQuality Assurance Specialist
CertificationsISO 9001 Lead Implementer, Internal AuditorISO 9001 Auditor, QA Certifications
Work EnvironmentImplementing and customizing QMS processes, working with cross-functional teamsMonitoring, testing, and auditing products/processes for quality compliance
Employer & IndustryManufacturing, Healthcare, Automotive, requiring QMS setupManufacturing, Software, Healthcare, focusing on product/service quality

Professional Qms Implementation focuses on establishing and customizing quality management systems within organizations, ensuring compliance and process integration. In contrast, a Quality Assurance Specialist primarily monitors and audits existing processes to maintain quality standards. Both roles require similar certifications but differ in scope and daily responsibilities.

What are some common challenges faced during the implementation of a Quality Management System (QMS), and how can professionals address them?

Professionals implementing a QMS often encounter challenges such as resistance to change, lack of employee engagement, and difficulty aligning new processes with existing workflows. To address these, it's crucial to communicate the benefits of the QMS clearly, involve staff at all levels early in the process, and provide ongoing training and support. Collaboration with cross-functional teams and regular feedback sessions can also help smooth the transition and ensure successful adoption of the QMS.
What cities in Michigan are hiring for Professional Qms Implementation jobs? Cities in Michigan with the most Professional Qms Implementation job openings:
Professional Qms Implementation jobs near you
Project Manager - Healthmark QMS, Defined Term (Remote in EST)

Project Manager - Healthmark QMS, Defined Term (Remote in EST)

Getinge

Lansing, MI • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 20 days ago

Getinge rating

9.3

Company rating: 9.3 out of 10

Based on 14 frontline employees who took The Breakroom Quiz

9th of 430 rated machine equipment manufacturers

Job description

With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Project Manager - Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include the development of project timelines, project team assembly, managing the schedule and maintaining effective communication through the project. This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.
Job Responsibilities and Essential Duties:
  • Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams.
  • Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.
  • Develop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.
  • Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.
  • Lead project coordination across the following QMS enhancement areas: Product Development Process, Receiving Inspection, Complaints & Vigilance, Validation, Device History Records (DHRs), Inspection & In-Process Controls, Corrective and Preventive Action (CAPA), and Training.
  • Support SOP development, gap closure documentation, and audit-readiness activities within scope.
  • Develop and present structured status reports to project teams and senior leadership on a defined cadence.
  • Escalate risk and issues proactively; recommend resolution paths with supporting analysis.
  • Contribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark's program management function.
  • Identify process improvement opportunities within the QMS implementation approach and recommend enhancements.
  • Collaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements.
  • Proficiency in Microsoft Project and/or equivalent project scheduling tools (Smartsheet, Monday.com); strong Microsoft 365 skills (Teams, SharePoint, Excel).

Required Knowledge, Skills and Abilities:
  • Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026.
  • Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle.
  • Demonstrated hands-on experience with the following QMS process areas: Product Development Process / Design Controls, Receiving Inspection, Complaints & Vigilance / MDR reporting, Validation (IQ/OQ/PQ), Device History Records, Inspection and In-Process Controls, CAPA, and Training.
  • Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous.
  • Demonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred).
  • Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials.
  • Experience managing cross-functional teams in a matrixed organizational environment without direct line authority.
  • Excellent written and verbal communication skills; ability to present complex regulatory and project information clearly to both technical and executive audiences.
  • Proven ability to influence, align, and lead cross-functional stakeholders without direct supervisory authority.
  • Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments.

Minimum Requirements:
  • Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related field required.
  • Master's degree or advanced technical credential a plus.
  • Minimum 5 years of experience in project or program management roles within the medical device industry.
  • Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485 in a regulated medical device environment.
  • Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions or regulatory remediation projects is strongly preferred.
  • PMP (Project Management Professional) certification is highly desired.

Quality Requirements:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
  • Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
  • Attend all required Quality & Compliance training at the specified interval.
  • Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:
  • Primarily office/hybrid environment; use of computer, telephone, and related office accessories to complete assignments.
  • May work extended hours during peak milestones or audit preparation cycles.
  • Occasional domestic travel may be required (estimated up to 20-25% depending on site-based activities).
  • Physical requirements: ability to sit/stand at a workstation for extended periods; occasional lifting up to 20 lbs.

The physical demands described here are a 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.
The salary range for this position is between $120,160 to $150,000 per year depending on experience and location.
#LI-MV1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
  • Parental and Caregiver Leave
  • Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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About Getinge

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Dr Wayne, NJ, US

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