Quality Engineer

2 weeks ago

Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

Job Title: Quality Engineer

Location: Pittsburgh, PA

Job Description:

We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing verification and validation (V&V) planning.

Key Responsibilities:

  • Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ) and MSA of internal processes.
  • Work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.
  • Interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
  • Assist with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. Participates in internal audits conducted by internal employees and regulatory agencies.
  • Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
  • Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions.

Required Skills:

  • Bachelors degree in Engineering, Quality, or a related field.
  • 8+ years of experience in medical device quality engineering or a related field.
  • Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
  • Experience with Design Control, Process Validation, CAPA, and Supplier Quality.

Nice to Have:

  • Proficiency in statistical analysis tools (Minitab, JMP, Excel) and problem-solving methodologies (8D, DMAIC).
  • Certified Quality Engineer (CQE) or Six Sigma certification.

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

  • Flexible work
  • Healthcare including dental, vision, mental health, and well-being programs
  • Financial well-being programs such as 401(k) and Employee Share Ownership Plan
  • Paid time off and paid holidays
  • Paid parental leave
  • Family building benefits like adoption assistance, surrogacy, and cryopreservation
  • Social well-being benefits like subsidized back-up child/elder care and tutoring
  • Mentoring, coaching and learning programs
  • Employee Resource Groups
  • Disaster Relief

About Capgemini Engineering

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. 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, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of 22.5 billion.

Get the Future You Want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. 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 accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

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

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.

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.

  • Quality Engineer

    6 hours ago

    Pittsburgh, Pennsylvania, United States Holtec International Full time

    QUALITY ENGINEER – HOLTEC Manufacturing Division: East Pittsburgh, PA QUALITY ENGINEER ROLES and RESPONSIBILITY: Holtec Quality Engineer is responsible to provide a technical foundation for developing/ supporting Holtec operations as required to comply with the requirements of 10CFR50 Appendix B, NQA-1, ASME Section III, ASME Section VIII, ISO 9000...

  • Quality Engineer

    7 hours ago

    Pittsburgh, Pennsylvania, United States Holtec International Full time

    QUALITY ENGINEER ROLES and RESPONSIBILITY: Holtec Quality Engineer is responsible to provide a technical foundation for developing/ supporting Holtec operations as required to comply with the requirements of 10CFR50 Appendix B, NQA-1, ISO 9000 and other industry consensus. The Quality Engineer reports directly to the HMD Quality Manager or the Holtec...

  • Quality Engineer

    1 day ago

    Pittsburgh, Pennsylvania, United States Capgemini Full time

    Quality Engineer - MedTech-078803 Description Job Title: Quality Engineer Location: Pittsburgh, PA Job Description: We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design...

  • Quality Engineer

    4 weeks ago

    Pittsburgh, Pennsylvania, United States Axiom Software Solutions Limited Full time

    Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. •Support Design Control activities by ensuring compliance with FDA and international regulations. •Lead and participate in Design Failure Modes and Effects Analysis...

  • Quality Engineer

    3 weeks ago

    Pittsburgh, Pennsylvania, United States Capgemini Full time

    Job Title: Quality EngineerLocation: Pittsburgh, PAJob Description:We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing...

  • Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    Job Title: Quality EngineerLocation: Pittsburgh, PAJob Description:We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing...

  • Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    Job Title: Quality EngineerLocation: Pittsburgh, PAJob Description:We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing...

  • Quality Engineer

    3 weeks ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    Job Title: Quality EngineerLocation: Pittsburgh, PAJob Description:We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing...

  • Quality Engineer

    3 weeks ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    Job Title: Quality Engineer Location: Pittsburgh, PA Job Description: We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing...

  • Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States SSi People Full time

    Job Title: Quality Engineer - CAPALocation: Pittsburgh, PAJob Description: As a Quality Engineer specializing in Corrective and Preventive Actions (CAPA), you will be the go-to expert for all CAPA-related matters. You will be responsible for reviewing, advising, and facilitating CAPA investigations, ensuring effective solutions and monitoring their...

  • Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States SSi People Full time

    Job Title: Quality Engineer - CAPA Location: Pittsburgh, PA Job Description: As a Quality Engineer specializing in Corrective and Preventive Actions (CAPA), you will be the go-to expert for all CAPA-related matters. You will be responsible for reviewing, advising, and facilitating CAPA investigations, ensuring effective solutions and monitoring their...

  • Supplier Quality Engineer

    7 days ago

    Pittsburgh, Pennsylvania, United States Holtec International Full time

    QUALITY ENGINEER ROLES and RESPONSIBILITY: Holtec Quality Engineer is responsible to provide a technical foundation for developing/ supporting Holtec operations as required to comply with the requirements of 10CFR50 Appendix B, NQA-1, ASME Section III, ASME Section VIII, ISO 9000 and other industry consensus. The Quality Engineer shallprovide oversight...

  • Senior Quality Engineer

    14 hours ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    About Capgemini Engineering">Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds.">We are a world leader in engineering and R&D services, helping clients accelerate their journey towards Intelligent Industry.">In our organization, you...

  • Quality Engineering Lead

    6 days ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    About the RoleCapgemini Engineering is a world leader in engineering and R&D services, combining its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds.This position will involve leading and supporting design control activities, ensuring compliance with FDA and...

  • Engineering Quality Specialist

    6 hours ago

    Pittsburgh, Pennsylvania, United States Capgemini Engineering Full time

    About Capgemini Engineering">We combine our broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds.">We help clients accelerate their journey towards Intelligent Industry by providing top-notch engineering and R&D services.">With over 55,000 engineer and scientist team...

  • Senior Quality Engineer

    1 day ago

    Pittsburgh, Pennsylvania, United States Capgemini Full time

    Senior Quality Engineer - Medical Tech.-078804 Description Job description: •Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. •Support Design Control activities by ensuring compliance with FDA and international...

  • Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Diverse Lynx Full time

    Role: Quality EngineerLocation: Pittsburgh, PA and Columbus,OH (Onsite)ContractJob Description: Selenium automation using Java Agile Way of Working, Selenium QA Selenium automation Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants...

  • Senior Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Capgemini Full time

    Job description:•Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage.•Support Design Control activities by ensuring compliance with FDA and international regulations.•Lead and participate in Design Failure Modes and...

  • Senior Quality Engineer

    6 days ago

    Pittsburgh, Pennsylvania, United States Capgemini Full time

    Job description: • Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. • Support Design Control activities by ensuring compliance with FDA and international regulations. • Lead and participate in Design Failure Modes...

  • Senior Quality Engineer

    1 week ago

    Pittsburgh, Pennsylvania, United States Capgemini Full time

    Job description: • Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. • Support Design Control activities by ensuring compliance with FDA and international regulations. • Lead and participate in Design Failure Modes...