Senior Design Quality Engineer

Our client is seeking a dedicated and experienced Senior Design Quality Engineer to join their dynamic team. As a Senior Design Quality Engineer, you will be part of the Quality Assurance department supporting cross-functional teams. The ideal candidate will demonstrate strong analytical skills, effective communication, and a proactive approach to quality management, which will align successfully in the organization.

Job Title: Senior Design Quality Engineer

Location: Andover, Massachusetts

Contract on W2

What's the Job?

• Serve as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
• Establish and maintain Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR), ensuring complete traceability from user needs through verification and validation evidence
• Lead and maintain risk management activities, including hazard analysis, FMEA, and risk files, integrating risk controls into design and validation activities
• Provide quality oversight of software Software Development Life Cycle (SDLC) activities, ensuring compliance with standards such as IEC 62304 and integrating with system-level risk management
• Support verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
  
  
  

What's Needed?

• 10 years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
• Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
• Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
• Experience supporting software quality within the SDLC and understanding of software risk management principles
• Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
  
  
  

What's in it for me?

• Collaborate with a talented and diverse team of professionals
• Engage in meaningful projects that foster professional growth and development
• Work in a supportive environment that values quality and compliance
• Be part of a forward-thinking organization committed to excellence
  
  
  

Upon Completion Of Waiting Period Consultants Are Eligible For

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay
  
  
  

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.