Quality Engineer

Staff Design Quality Engineer – Design Quality

📍 Location: Marlborough, MA (Hybrid – 3–4 days onsite)

📅 Start Date: Immediate

🕒 Duration: 49 Weeks (Potential Temp-to-Perm)

Job Summary

Seeking a highly experienced Staff Design Quality Engineer to provide quality oversight for complex IVD (In Vitro Diagnostics) medical device development programs, high-risk design changes, validation activities, and design transfer initiatives.

This position serves as a senior technical quality leader responsible for ensuring compliance, product quality, risk management, and regulatory readiness across the product development lifecycle.

Key Responsibilities

• Lead quality oversight for complex IVD product development and lifecycle programs
• Review and approve design control deliverables including:
• Design & development plans
• Risk management files
• Validation strategies
• Design reviews
• Traceability matrices
• Design transfer documentation
• Translate customer, clinical, laboratory, manufacturing, and regulatory requirements into robust design inputs/outputs
• Evaluate major design changes, assay updates, usability updates, and transfer activities
• Provide quality leadership for analytical and clinical validation programs
• Support investigations, CAPAs, nonconformance assessments, and risk-based decision making
• Improve design quality processes, governance, training, and inspection readiness
• Support audits, regulatory inspections, and customer-facing initiatives
• Mentor teams and provide technical consultation on complex quality matters

Required Qualifications

• 8 years of experience in:
• Design Quality
• Development Quality
• Quality Engineering
• Medical Device / IVD environments
• Strong expertise in:
• Design Controls
• Risk Management
• Verification & Validation (V&V)
• Design Transfer
• Lifecycle Change Control
• Experience with:
• FDA QMSR
• ISO 13485
• ISO 14971
• GMP compliance
• Experience supporting IVD platforms, diagnostics, regulated product development, or pharma collaborations
• Ability to make independent technical quality decisions

Preferred Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, Life Sciences, or related field
• Advanced degree preferred
• ASQ Certification preferred
• Regulatory Affairs Certification (RAC) preferred
• Lead Auditor or advanced risk management training
• Experience in multi-site regulated environments

Additional Notes

• Strong preference for candidates with IVD experience
• Background in Quality / Regulatory Affairs is highly preferred
• Must be open to contract-to-hire conversion based on business needs
• Experience in medical device design & development with emphasis on design control and risk management preferred

Pride Global and its affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity

Pride Global and its affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment

Pride Global and its affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation