Sr. Quality Assurance Engineer (Medical Device)

Sr. Quality Assurance Engineer (Medical Device)

Engineering

iMPact Business Group

Redmond, WA 98052

$65.00 - $70.00

Posted 09/28/2026

Contract

Contract

Job ID: 27633

Job Description

18-Month+ Contract | 40 Hours/Week | Monday–Thursday, 7:30 AM–5:00/6:00 PM | Friday Flex as Needed | Potential 1 Remote Day/Week

Our client, a global leader in the medical device industry, has an immediate opening for a Quality Assurance Engineer for an 18-month+ contract. This opportunity is ideal for a quality professional with strong manufacturing experience who can drive non-conformance investigations, CAPA activities, supplier quality initiatives, and process improvements within a highly regulated environment.

Key Focus

• Non-Conformances (NC) and CAPA
• Supplier Quality and Corrective Actions
• Manufacturing and Process Quality
• PPAP and Change Management
• Process and Equipment Validation
• Medical Device Quality Systems

What You'll Do

• Partner with Operations and cross-functional teams to ensure product and process quality performance.

• Own internal and supplier-driven Non-Conformances (NCs) and CAPAs, including timely processing and closure within TrackWise.

• Investigate and disposition non-conforming product through the Material Review Board (MRB) process.

• Support manufacturing-related complaint investigations and product field actions.

• Collaborate with suppliers to resolve quality issues and initiate Supplier Corrective Action Requests (SCARs) when required.

• Manage Supplier Initiated Change Requests (SICRs) and coordinate cross-functional assessment and approval.

• Support manufacturing transfers between plants and facilities.

• Identify and execute opportunities for supplier part certification.

• Support improvements to internal manufacturing and distribution processes.

• Assess internal and supplier-proposed changes, including Production Part Approval Process (PPAP) activities.

• Participate in the creation and review of new or modified quality procedures.

• Support process and equipment validation, qualification, and Measurement System Analysis (MSA).

• Maintain quality KPIs, analyze trends, and initiate appropriate corrective actions.

• What We're Looking For

• Bachelor's degree in a science or technical field.

• Minimum 3 years of quality experience, including operations or manufacturing experience.

• Hands-on CAPA and Non-Conformance experience.

• Experience with SAP or other ERP systems.

• TrackWise experience is highly preferred.

• Strong understanding of quality concepts including Risk Management, CAPA, Audits, Statistics, DMAIC, and DFSS.

• CQE, Lean Six Sigma Green Belt (LSSGB), or Lean Six Sigma Black Belt (LSSBB) certification preferred.

• Medical device industry experience preferred.

• Familiarity with ISO 13485, GDP, GMP, and U.S. and international medical device regulations preferred.

• Experience working with regulatory agencies such as the FDA, MoH, or TÜV is a plus.

• About Redmond, WA

• Discover exciting job opportunities in the vibrant Redmond, Washington area! Nestled in the scenic Pacific Northwest, Redmond offers job seekers a unique blend of tech innovation, outdoor recreation, and cultural charm. Known as the "Bicycle Capital of the Northwest," Redmond boasts an extensive network of bike trails perfect for exploring the stunning Cascade Mountains. With nearby attractions like the iconic Space Needle in Seattle, the picturesque wineries in Woodinville, and the world-renowned Museum of Glass in Tacoma, there's no shortage of adventures to be had. Whether you're drawn to the bustling tech scene with companies like Microsoft and Nintendo, or craving a taste of the local cuisine at the Food Truck Roundup, Redmond has something for everyone. Join us in experiencing the dynamic opportunities and endless possibilities that await in this thriving region!

• Contract positions

• Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.

• Permanent placed employees

• Paid by and qualify for benefits in accordance with the policies of the hiring company.

• Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.

• Internal Positions

• We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.

• Recruiters

• Account Managers

• Learn more about working with iMPact Business Group

• Related Jobs

• There are currently no related jobs. Please sign up for Job Alerts.

• Loading...

• EH&S Coordinator

• Redmond, WA

• Apply

• Apply Online

• Apply with LinkedIn

• Apply with Facebook

• Apply with X

• Apply Later

Send an email reminder to:

• Send

• Cancel

• Job Alerts

• Get notified when similar jobs are posted.

• Sign Up for Alerts

• Share This Job

• LinkedIn

• Facebook

• Twitter

• Copy Link

• Apply with LinkedIn

• Apply with Facebook

• Apply with X

• Find your next career opportunity

• REMOTE

• IT

• Engineering

• Accounting & Finance

• Other

• iMPact Business Group is a professional staffing agency located in Grand Rapids, MI, and Tampa, FL. We were founded in 2004 and service candidates and clients nationwide. Our areas of specialization are in IT, Engineering, Finance/Accounting, and Business Administration/Process (HR, Marketing, Admin jobs, etc). Opportunities are available nationwide as well as remote.

• Opportunities

• Information Technology

• Engineering & Supply Chain

• Accounting & Finance

• Other (Admin, HR, Marketing)

• Remote

• EMPLOYERS

• Partner With iMPact

• Request An Employee

• About

• About Us

• Locations - Grand Rapids, MI

• Locations - Tampa, FL

• Fact Sheet

• Media Kit

• Careers

• Resources

• Blog

• Webinars & Workshops

• Resume Guide

• Podcast