What are the responsibilities and job description for the Quality Engineer - MedTech position at Capgemini Engineering?
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:
Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:
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.
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.
- Bachelor’s 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.
- Proficiency in statistical analysis tools (Minitab, JMP, Excel) and problem-solving methodologies (8D, DMAIC).
- Certified Quality Engineer (CQE) or Six Sigma certification.
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
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.
