Capgemini

Capgemini

Junior Medical Quality Engineer

Pittsburg, US · Junior · Full-time

Sponsorship not specified$54k-$122kDetected 2 days ago
LLMsStatisticsAccessibilityProcess ImprovementFDA RegulatoryMedical DevicesProblem SolvingRegulatory Affairs

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odds of building a lasting career here

53Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • 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 most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide 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 are the same

Responsibilities

  • Supports 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 (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.
  • Participate in protocol review and support testing strategy, ensuring robust verification and validation processes.
  • 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.
  • Develops various inspection techniques and procedures to ensure product integrity to design specifications.
  • Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions.
  • Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs).

Requirements

  • 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, NC and Supplier Quality.
  • Proficiency in statistical analysis tools (MinitabJD) and problem-solving methodologies (8D, DMAIC).
  • This is a general description of the Duties, Responsibilities and Qualifications required for this position.

Nice to have

  • Review protocols and participate in V&V planning to ensure alignment with product requirements.
  • 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.
  • Participates in internal audits conducted by internal employees and regulatory agencies.

Skills

  • Your Skills and Experience

Compensation

  • $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.
  • 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.
  • 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.

Benefits

  • Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees.
  • In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:
  • 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
  • Other benefits as provided by local policy and eligibility

Company info

  • 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 most innovative companies unleash their potential.

Equal opportunity

  • Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace.
  • 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.
  • If you need assistance or accommodation, please reach out to your recruiting contact.
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This listing is sourced directly from Capgemini's careers page and normalized into a canonical job model.