Junior Medical Quality Engineer

Capgemini; Pittsburg (CA); On-site; USD 54,000 - 122,000; Full time

Benefits offered by this job

Paid time off

Medical coverage

Retirement plans

Job summary

Capgemini Engineering, a world leader in engineering services, is hiring a Medical Junior Quality Engineer for an onsite role in Pittsburgh, PA. You will support design quality activities across new product development, perform DFMEA, risk assessments, and ensure V&V alignment with design requirements.

The role requires a Bachelor’s in Engineering/Quality, 3+ years in medical device quality, and strong ISO/FDA knowledge. Proficiency with Minitab and 8D/DMAIC is desired, CQE or Six Sigma a plus.

Qualifications

• Bachelor’s degree in Engineering, Quality, or a related field.
• 3+ years of experience in medical device quality engineering.
• Strong knowledge of ISO 13485, FDA QSR (21CFR Part 820), EU MDR, and ISO 14971.
• Experience with Design Control, Process Validation, CAPA, NC and Supplier Quality.
• Proficiency in statistical analysis tools (Minitab) and problem-solving methodologies (8D, DMAIC).
• CQE or Six Sigma certification is a plus.

Responsibilities

• Supports design quality activities throughout new product development, including design reviews and risk management.
• Lead DFMEA and risk assessments.
• Review protocols and V&V planning to ensure alignment with requirements.
• Support equipment qualification and process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA and international regulations.
• Collaborate with Manufacturing and suppliers on CAPAs and problem solving.

Skills

Quality engineering

Statistical analysis

Problem solving

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Quality

Master’s preferred

Tools

Minitab

Job description

Introduction

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 mostinnovative companies unleash their potential. From autonomous cars to life‑saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe same

Location

This is an onsite role in Pittsburgh, PA

About the Job

This is a Medical Junior Quality Engineer role, to perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Your Role

• Supports design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.


• Supports design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.


• Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments.


• Participate in DFMEA, PFMEA, process flow, control plan, and risk assessment activities to ensure design and manufacturing risks are identified, mitigated, and documented.


• Review protocols and participate in V&V planning to ensure alignment with product requirements.


• Review verification, validation, inspection, equipment qualification, and process validation protocols to ensure alignment with product requirements, risk controls, and design transfer needs.


• Participate in protocol review and support testing strategy, ensuring robust verification and validation processes.


• Support execution and documentation of equipment qualification and process validation activities, including IQ/OQ/PQ, validation reports, and related production readiness evidence.


• Support Design Control activities by ensuring compliance with FDA and international regulations.


• Support supplier/process readiness activities, including review of supplier documentation, inspection results, capability studies, MSA/Gage R&R, and approval packages.


• Develop and execute supplier qualification processes, including supplier contracts and PPAPs.


• Develops various inspection techniques and procedures to ensure product integrity to design specifications.


• Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures.


• Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging.


• Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control.


• Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies.


• Recommends process monitoring devices where applicable.


• Assists 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.


• Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs).

Your Skills and Experience

• Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred).


• 3+ years of experience in medical device quality engineering or a related field.


• Strong knowledge of ISO 13485, FDA QSR (21CFR Part 820), EU MDR, and risk management (ISO 14971).


• Experience with Design Control, Process Validation, CAPA, NC and Supplier Quality.


• Proficiency in statistical analysis tools (MinitabJD) and problem-solving methodologies (8D, DMAIC).


• Certified Quality Engineer (CQE) or Six Sigma certification is a plus.


• Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals.


• Quality Orientation-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.


• Decision Making- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.


• Performance/Work Standards-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks. (Flawless Execution of the Basics).


• Information Monitoring- Setting up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

Base Compensation Range

The base compensation range for this role in the posted location is: $53,580 - $122,400. 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.

Benefits

• 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.

Equal Opportunity Employer

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.

Other Information

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. 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. 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 businessneeds. 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.