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Contract Capa Engineer Jobs in Tennessee (NOW HIRING)

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Contract Capa Engineer information

What is a contract CAPA engineer?

A Contract CAPA Engineer is a professional hired on a temporary or project basis to manage and oversee Corrective and Preventive Action (CAPA) processes within an organization, typically in regulated industries such as pharmaceuticals, medical devices, or manufacturing. Their primary responsibility is to investigate issues, identify root causes, and implement solutions to prevent recurrence of non-conformities. They ensure that CAPA processes meet regulatory standards and help maintain compliance with industry guidelines. Contract CAPA Engineers often work with cross-functional teams to drive continuous improvement and ensure product quality.

What are the key skills and qualifications needed to thrive as a contract CAPA engineer?

To excel as a Contract CAPA Engineer, you need a strong background in quality engineering, root cause analysis, and regulatory compliance, often supported by a degree in engineering or a related field. Expertise in CAPA management systems, quality management software (like TrackWise), and knowledge of ISO 13485 or FDA regulations are typically required. Strong analytical thinking, attention to detail, and effective communication skills help drive successful corrective and preventive actions. These competencies ensure regulatory compliance, minimize risks, and maintain product quality in regulated industries.

What are some common challenges faced by a contract CAPA engineer when implementing corrective and preventive actions across multiple client sites?

As a Contract CAPA Engineer, one of the main challenges is adapting to different organizational processes and quality management systems at each client site. Each company may have unique documentation standards, regulatory requirements, and communication protocols, which can complicate the investigation and resolution of quality issues. Balancing multiple projects, aligning stakeholders, and ensuring timely closure of CAPA actions while strictly adhering to compliance standards requires strong organizational and interpersonal skills. Successful engineers proactively build rapport with client teams and remain detail-oriented to ensure all corrective and preventive actions are both effective and audit-ready.

What is the difference between Contract Capa Engineer vs Contract Failure Analysis Engineer?

AspectContract Capa EngineerContract Failure Analysis Engineer
Required CredentialsBachelor's in Engineering, Six Sigma, Root Cause AnalysisBachelor's in Engineering, Six Sigma, Root Cause Analysis
Work EnvironmentManufacturing, Aerospace, AutomotiveManufacturing, Aerospace, Automotive
Employer & Industry UsageQuality departments, Reliability teamsQuality departments, Reliability teams
Common Search & ComparisonYesYes

Both roles focus on quality and reliability, requiring similar certifications and working in manufacturing or aerospace industries. The Contract Capa Engineer primarily manages corrective and preventive actions to address issues, while the Contract Failure Analysis Engineer investigates root causes of failures. They often collaborate but serve distinct functions within quality assurance teams.

What job categories do people searching Contract Capa Engineer jobs in Tennessee look for?

The top searched job categories for Contract Capa Engineer jobs in Tennessee are:

Microbiologist Sterilization Manager

Medtronic

Memphis, TN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

New


Medtronic rating

7.9

Company rating: 7.9 out of 10

Based on 180 frontline employees who took The Breakroom Quiz

154th of 545 rated manufacturers


Job description

We anticipate the application window for this opening will close on - 11 Sep 2026


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 Life

The Microbiologist Sterilization Manager is part of the Global Operations & Supply Chain organization and provides microbiology and sterility assurance leadership for manufacturing sites within the Central Region. The team partners closely with Quality, Operations, Engineering, and Research & Development to ensure microbiological quality, regulatory compliance, and effective implementation of sterilization and contamination control programs across multiple facilities.

The position may be based in Fort Worth, TX; Memphis, TN; Warsaw, IN; or Milwaukee, WI. This position requires onsite presence a minimum of four (4) days per week. The role also requires up to 25% domestic travel.

This role provides technical and people leadership for microbiology and sterility assurance activities supporting medical device manufacturing operations. The position is responsible for ensuring compliance with microbiological and sterilization requirements, leading continuous improvement initiatives, supporting regulatory inspections and audits, and developing a high-performing team focused on product quality and patient safety.

Primary Responsibilities

  • Lead microbiology and sterility assurance programs that support manufacturing operations and regulatory compliance across assigned sites.

  • Provide leadership and development for engineers and scientists responsible for microbiological testing, environmental monitoring, sterilization, and contamination control activities.

  • Serve as the site and regional subject matter expert for microbiology and sterilization and provide guidance on technical and compliance-related issues.

  • Oversee the development, execution, and maintenance of microbiology, sterilization, environmental monitoring, and controlled environment programs.

  • Lead investigations, corrective and preventive action (CAPA) activities, and continuous improvement initiatives related to microbiological quality and sterility assurance.

  • Monitor, analyze, and report key performance indicators and quality metrics to support operational excellence and compliance objectives.

  • Support new product introductions, process transfers, and validation activities by establishing microbiology and sterilization requirements for manufacturing implementation.

  • Represent microbiology and sterility assurance functions during internal audits, regulatory inspections, and external assessments.

Required Qualifications:

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

  • Bachelor's degree in science or technical field with 5+ years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced Degree in Science or technical field with 3+ years of work experience in microbiology, sterilization, and/or biocompatibility experience.

  • Requires a minimum of 2 years of prior experience supervising or managing others.

Preferred Qualifications

  • Experience in the front room of FDA inspections or notified body audits.

  • Experience serving as a subject matter expert during audits, inspections, or regulatory assessments.

  • Demonstrated understanding of the industrial sterilization business and contract sterilizer operations.

  • Experience supporting microbiology and sterilization programs within a regulated manufacturing environment.

  • Experience with controlled environment monitoring, process water systems, and/or industrial sterilization processes such as Ethylene Oxide (EO), Vaporized Hydrogen Peroxide (VHP), Moist Heat, Dry Heat, or Radiation sterilization.

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 & Compensation

Medtronic 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.

Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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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