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Capgemini

Global consulting, technology services, outsourcing

Junior Medical Quality Engineer

Biomedical Engineering & Medical DevicesUpdated on Nov 14
Full-timePittsburgh, PA, USA

About the Job

Requirements

  • A bachelor's degree in Engineering, Quality, or a related field is required; a master's degree is preferred.
  • At least 3 years of experience in medical device quality engineering or a related field.
  • Strong knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), EU MDR, and ISO 14971 risk management.
  • Experience with Design Control, Process Validation, CAPA, nonconformances, and Supplier Quality.
  • Proficiency in statistical analysis tools such as Minitab and problem-solving methodologies including 8D and DMAIC.

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 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 identify, mitigate, and document design and manufacturing risks.
  • 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; support execution and documentation of equipment qualification and process validation activities, including IQ/OQ/PQ, validation reports, and production readiness evidence.
  • 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, MSA/Gage R&R, and approval packages.
  • Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
  • Develop inspection techniques and procedures to ensure product integrity to design specifications; write, approve, and implement Incoming, In-Process, Final Inspection, and operator self-inspection procedures.
  • Work with other Quality Engineers and Metrology Lab personnel to develop product gaging.
  • Work with suppliers, management, engineers, and manufacturing associates to resolve quality problems; assist these groups with capability studies and application of statistical quality control.
  • Interface with Manufacturing Engineers to review new-product processes and coordinate process validations and capability studies; recommend process monitoring devices where applicable.
  • Assist with complaint investigation and documentation; interface with Regulatory Affairs to support UL, IEC, and FDA submissions.
  • Participate in internal audits conducted by internal employees and regulatory agencies.
  • Manage and drive timely resolution of nonconformances and corrective and preventive actions (CAPAs).

Desired Qualifications

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

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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