Skip to main content
Post your resume and find your next job on Indeed!

Supplier Quality Engineer Medical Device jobs

Sort by: -
    • 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred).
    • Effectively work with customers, suppliers, and other team members to ensure a quick and effective containment and problem resolution through the 8D Problem…
    • Development, execution and maintenance of the supplier quality management systems including:
    • Interface with parts, materials and outsourcing suppliers on all…
    • Comply with all quality and safety requirements.
    • Excellent understanding of ISO 9001 and ISO 17025 quality standards.
    • We offer competitive market salaries.
    • Communicate with customers and suppliers on quality-related matters.
    • Review and approve documentation packages, supplier ITPs, and quality records.
    • Chez LION, on conçoit et fabrique des autobus scolaires électriques assemblés à 100 % au Québec.
    • Plus qu’un fabricant, on est un partenaire de confiance pour…
    • Pour un rôle clé avec un impact concret sur le quotidien des employés.
    • Des défis stimulants dans un contexte pancanadien.
    • Emploi stable à temps plein.
    • Entreprise en croissance, solidement implantée qui détient une excellente réputation.
    • Autonomie, rigueur et capacité d’adaptation.
    • Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
    • Develop and provide training to build quality awareness.
    • Collaborate with suppliers to establish approved supply chains and strong quality standards.
    • Integrate supplier quality data into internal risk assessments and…
    • L’Agent(e) Qualité est un point central des communications entre Mindcore, ses clients et ses fournisseurs.
    • Gestion des communications qualité avec les clients…
  • View similar jobs with this employer
    • 7+ years in quality engineering or quality systems role.
    • You will standardize quality processes across BUs and bring new acquisitions onto the AML quality…
  • View similar jobs with this employer
    • Your role as supplier compliance quality analyst will be to take the necessary.
    • You will be part of the Supplier compliance management team responsible for…
    • Review and approve quality agreements.
    • The Quality Director will collaborate across departments to foster a culture of quality, compliance, and operational…
    • Experience working with gas turbines or within the aerospace sector and in a quality assurance regulated environment preferred.
Get e-mail updates for the latest Supplier Quality Engineer Medical Device jobs

By creating a job alert, you agree to our Terms . You can change your consent settings at any time by unsubscribing or as detailed in our terms.

Career Resources:

Job Post Details

Senior Design Quality Engineer - job post

Capgemini
3.7 out of 5 stars
Burlington, ON
Permanent
Responded to 75% or more applications in the past 30 days, typically within 1 day.
You must create an Indeed account before continuing to the company website to apply

Job details

Job type

  • Permanent

Location

Burlington, ON

Benefits

Pulled from the full job description

  • Paid time off
  • Vision care
  • Dental care
  • Employee assistance program
  • Disability insurance
  • RRSP

Full job description

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Job Description

Location : Andover, MA - Onsite (4 days/week)


About the job you’re considering


Capgemini Engineering are actively looking for Senior Design Quality Engineer with senior QA who will be serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)


Your role


  • Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
  • Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
  • Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
  • Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
  • Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
  • Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
  • Leading or supporting CAPA, nonconformance investigations, and root-cause analysis to drive continuous improvement
  • Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

Your skills and experience


  • 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
  • Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
  • Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
  • Experience supporting software quality within the SDLC and understanding of software risk management principles
  • Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
  • Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
  • Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
  • Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

The base compensation range for this role in the posted location is:73,150 -146,300

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.


Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

  • Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
  • Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
  • Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
  • Life and disability insurance
  • Employee assistance programs
  • Other benefits as provided by local policy and eligibility

Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.


Disclaimers

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Click the following link for more information on your rights as an Applicant in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law


Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

Let Employers Find YouUpload Your Resume