Quality Engineer - TMV

Job Title: Quality Engineer - TMVJob DescriptionWe are seeking a highly experienced Principal Quality Engineer to lead post-acquisition quality remediation efforts at our Irvine, CA site. This onsite role will focus on the remediation, standardization, and sustainment of Process Failure Mode and Effects Analyses (PFMEAs) and Test Method Validation (TMV) documentation to ensure compliance with internal quality standards and applicable regulatory requirements. This role is ideal for a seasoned medical device quality professional with strong expertise in risk management, test method validation, and measurement system analysis, capable of independently assessing legacy documentation, developing remediation strategies, and collaborating cross‐functionally to integrate acquired products and processes into an established Quality Management System (QMS).ResponsibilitiesLead and execute PFMEA remediation activities, including gap assessments, risk re-evaluations, updates, and alignment to current manufacturing and process states.Own the remediation, development, and documentation of Test Method Validations (TMVs) for inspection, test, and measurement methods used in manufacturing and product verification.Evaluate legacy test methods for adequacy, robustness, and regulatory compliance; identify gaps and define remediation plans.Plan, execute, and review Gage Repeatability & Reproducibility (GR&R) studies as part of TMV and measurement system validation activities.Apply statistical techniques (e.g., GR&R, bias, linearity, stability) to assess measurement system capability and suitability.Ensure PFMEAs and TMVs comply with ISO standards, FDA Quality System Regulation (21 CFR 820), and internal quality procedures.Collaborate cross-functionally with R&D, Manufacturing Engineering, Quality Control, and Operations to define test requirements, acceptance criteria, and validation strategies.Support integration of acquired products, processes, and test methods into the parent company's QMS.Review and approve TMV protocols, reports, and supporting statistical analyses.Facilitate risk management and PFMEA reviews to ensure test methods adequately detect and control product and process risks.Ensure TMV and PFMEA changes are properly documented and implemented through formal change control processes.Support internal and external audits, inspections, and diligence activities related to test method validation and measurement systems.Identify opportunities to improve test method robustness and long-term sustainment of validation practices.Essential SkillsBachelor's degree in Engineering (Biomedical, Mechanical, Manufacturing, Industrial, or related field).5+ years of relevant Quality Engineering experience in the medical device industry.Proven experience leading PFMEA development and remediation.Strong hands-on experience with Test Method Validation (TMV).Required familiarity and working knowledge of GR&R and measurement system analysis.Ability to interpret and apply statistical data to validate inspection and test methods.Solid working knowledge of ISO standards and FDA QSR (21 CFR 820).Experience supporting remediation efforts in a post-acquisition or compliance-driven environment.Ability to work onsite in Irvine, CA.Excellent technical writing, analytical, and documentation skills.Ability to work independently and effectively lead cross-functional teams.Additional Skills & QualificationsExperience validating mechanical, dimensional, functional, or analytical test methods.Proficiency with statistical software or analysis tools (e.g., Minitab, JMP, Excel).Experience supporting FDA inspections and/or notified body audits.Understanding of verification and validation (V&V) activities and their linkage to risk management.Experience with electronic QMS systems (e.g., Agile, Windchill, Arena, MasterControl).Medical device manufacturing, inspection, or metrology.Work EnvironmentThis position is based onsite in Irvine, CA, allowing for direct collaboration with cross-functional teams. Employees enjoy 3 weeks of PTO and 10 paid holidays. The role demands a high level of technical proficiency and the ability to work independently in a fast-paced environment. The work environment supports the use of statistical analysis software such as Minitab and JMP, and involves working with electronic QMS systems.Job Type & LocationThis is a Contract position based out of Irvine, CA.Pay and BenefitsThe pay range for this position is $55.00 - $65.00/hr.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Irvine,CA.Application DeadlineThis position is anticipated to close on Mar 31, 2026.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleActalent is an equal opportunity employer.About ActalentActalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.