C

Capgemini

Global consulting, technology services, outsourcing

Junior Medical Quality Engineer

Full-Time
$53.6k - $122.4k/yr+ Variable incentives + Bonus + Commission
Mid
Bachelor's, Master's
Pittsburgh, PA, USA
In Person

About the job

Requirements
  • A bachelor's degree in Engineering, Quality, or a related field is required.
  • Three or more years of experience in medical device quality engineering or a related field is required.
  • Strong knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), EU Medical Device Regulation, and risk management under ISO 14971 is required.
  • Experience with Design Control, Process Validation, Corrective and Preventive Action, nonconformances, and Supplier Quality is required.
  • Proficiency in statistical analysis tools such as MinitabJD and problem-solving methodologies including 8D and DMAIC is required.
  • The role requires the ability to build strategic working relationships and use collaborative relationships to accomplish work goals.
  • The role requires quality orientation, including accurately checking processes and tasks and monitoring them over time.
  • The role requires decision-making based on issues, data from multiple sources, constraints, and probable consequences.
  • The role requires setting high performance standards and assuming accountability for completing assignments and tasks.
  • The role requires information monitoring through ongoing procedures for collecting and reviewing information needed to manage activities.
Responsibilities
  • Support design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
  • Support 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 and risk assessments, including DFMEA, PFMEA, process flow, control plan, and risk assessment activities.
  • Review protocols and participate in verification and validation planning to ensure alignment with product requirements.
  • Review verification, validation, inspection, equipment qualification, and process validation protocols for alignment with product requirements, risk controls, and design transfer needs.
  • Participate in protocol review and support testing strategy, including execution and documentation of equipment qualification and process validation activities such as IQ/OQ/PQ and validation reports.
  • Support Design Control activities to ensure compliance with FDA and international regulations.
  • Support supplier and process readiness activities, including review of supplier documentation, inspection results, capability studies, Measurement System Analysis/Gage Repeatability and Reproducibility, and approval packages.
  • Develop and execute supplier qualification processes, including supplier contracts and Production Part Approval Processes.
  • Develop and execute inspection techniques and procedures to ensure product integrity to design specifications.
  • Write, obtain approval for, and implement Incoming, In-Process, Final Inspection, and operator self-inspection procedures.
  • Work with Quality Engineers and Metrology Lab personnel to develop product gauging.
  • Work with suppliers, management, engineers, and manufacturing associates to resolve quality problems and assist with capability studies and statistical quality control.
  • Interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies.
  • Recommend process monitoring devices where applicable.
  • Assist with complaint investigation and documentation and interface with Regulatory Affairs to support UL, IEC, and FDA submissions.
  • Participate in internal audits conducted by employees and regulatory agencies.
  • Manage and drive timely resolution of nonconformances and corrective and preventive actions.
Desired Qualifications
  • A master's degree is preferred.
  • Certified Quality Engineer or Six Sigma certification is a plus.

About the company

Capgemini helps organizations in consulting, technology services, and outsourcing to drive digital transformation. Its offerings include strategy and transformation consulting; system integration, application development, and IT infrastructure management; and managed IT operations and business processes. It competes through a global footprint in over 50 countries with a local touch, applying AI, cloud, and cybersecurity to real-world problems. Its goal is to help clients achieve strategic objectives and improve efficiency through technology.

Company Size

10,001+

Company Stage

IPO

Headquarters

Paris, France

Founded

1967

Get referred to Capgemini

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • H1 2026 revenue reached €12.082 billion, up 8.8%, and guidance rose to 8.5%-9.0%.
  • HMRC’s June 2026 contract adds multi-year public-sector revenue and validates Capgemini’s sovereign-cloud pitch.
  • Generative and agentic AI exceeded 10% of Q4 2025 bookings, signaling durable demand momentum.

What critics are saying

  • Fit-for-Growth triggered about €700 million restructuring costs across 2026-2027, mostly in 2026.
  • June 30, 2026 filings cite recurring India transfer-pricing tax reassessments and active litigation.
  • AI services commoditize legacy consulting; WNS integration and workforce cuts threaten margin expansion by 2027.

What makes Capgemini unique

  • Capgemini’s October 2025 WNS acquisition created scaled Intelligent Operations and agentic AI delivery.
  • The June 2026 HMRC deal extends a 2004 relationship and embeds Capgemini in UK tax systems.
  • Capgemini’s September 2026 OpenAI Deployment Company investment deepens enterprise AI implementation access.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Paid Vacation

Flexible Work Hours

Remote Work Options

Professional Development Budget

Meal Benefits

Dental Insurance

Life Insurance

Performance Bonus

Hybrid Work Options

Growth & Insights and Company News

Headcount

6 month growth

↑ 5%

1 year growth

↑ 5%

2 year growth

↑ 5%
InfraSale
Sep 25th, 2026
Capgemini Expands Seattle Presence with Acquisition of Collinear Group

Capgemini has acquired Collinear Group, enhancing its consulting capabilities in the Seattle area. This move signifies a strategic expansion into the growing data center and technology consulting market, which is crucial for InfraSale's audience focused on infrastructure development. Observers should watch for how this acquisition impacts local data center projects and consulting services.

Associated Press
Sep 10th, 2026
42% of consumers confused by life insurance policies, 1 in 4 abandon purchase

Life insurers face a relevance crisis, according to the World Life Insurance Report 2027 from Capgemini and LIMRA. The study surveyed over 6,100 consumers globally and found that whilst 47% consider buying life insurance, more than 40% feel confused or unconvinced by available information. One in four abandon the purchase process. Younger consumers aged 18-40 are particularly affected, with 28% dropping out before completion. Technical language, affordability concerns, and perceived irrelevance drive these exits. The report reveals nearly 40% of policyholders rarely hear from insurers post-purchase, and half who discontinue do so within three years. However, best-in-class insurers—representing just 10% of carriers—achieved 41% higher revenue growth and 12% lower lapse rates through personalised engagement and data-driven strategies.

The Register
Aug 20th, 2026
HMRC awards Capgemini $47M SAP migration contract, extending 28-year relationship

The UK's HM Revenue & Customs has awarded Capgemini a £37 million contract to migrate its Enterprise Tax Management Platform from SAP ECC 6.0 to S/4HANA. The contract runs until 2032, potentially extending Capgemini's involvement with HMRC's tax systems to 28 years since the relationship began in 2004. The platform handles more than £800 billion in tax revenue and payments annually for 40,000 users. HMRC insisted the procurement was fair and competitive, with several bidders competing from the Digital Legacy Application Services framework. Capgemini became HMRC's lead technology supplier in 2004 under the Aspire contract. A 2014 parliamentary committee found that Aspire cost £7.9 billion between 2004 and 2014, generating £1.2 billion in combined profit for Capgemini and Fujitsu.

Yahoo Finance
Jul 30th, 2026
Capgemini H1 net profit drops 31% to $538M despite 8.8% revenue rise and raised FY outlook

French technology company Capgemini reported a 31% drop in net profit to €498 million in the first half of the year, down from €724 million in the same period last year, due to higher expenses. Normalised earnings per share fell 12% to €5.29. Revenue climbed 8.8% to €12.08 billion from €11.11 billion. The company's operating margin rose 9.3% to €1.51 billion. Net other operating income and expenses increased to €628 million from €401 million in the prior-year period. Capgemini raised its fiscal 2026 revenue growth outlook to around 8.5% to 9.0% at constant exchange rates, up from its earlier forecast of 6.5% to 8.5%.

Yahoo Finance
Jul 30th, 2026
Capgemini raises 2026 revenue growth target to 8.5-9% after strong H1 performance

Capgemini has upgraded its 2026 revenue growth outlook following strong first-half performance. The French IT services firm now expects constant currency revenue growth of around 8.5% to 9.0%, up from its previous target of 6.5% to 8.5%. The company reported revenues of €12.1 billion in the first half of 2026, up 8.8% year-on-year, with constant currency growth of 11.3%. Operating margin reached 12.5% of revenues, up 10 basis points year-on-year. Chief executive Aiman Ezzat attributed the performance to strong demand for AI-driven transformation services, particularly agentic AI and physical AI solutions. The company's newly integrated Intelligent Business Operations business line, following the WNS acquisition, is generating significant commercial traction. Capgemini maintained its operating margin target of 13.6% to 13.8% and organic free cash flow guidance of €1.8 billion to €1.9 billion for the full year.