Sr Quality Engineer
Job Description
We are seeking a highly skilled and motivated Senior Quality Engineer to join our dynamic team. The ideal candidate will provide technical expertise and leadership in support of Quality, Manufacturing, and R&D teams. This role involves driving compliance, implementing quality improvement initiatives, and ensuring the highest standards in product and process quality. The Senior Quality Engineer will be instrumental in supporting process control, statistical analysis, and product validation efforts in a fast-paced, regulated manufacturing environment.
Key Responsibilities
- Ensure compliance with ISO 13485 regulations and FDA audit requirements.
- Implement measurable, effective corrective and preventive actions (CAPA).
- Provide guidance and direction to manufacturing, engineering, and materials teams in quality performance measurement.
- Improve and monitor inspection processes and support ISO 13485 certifications.
- Deliver hands-on support in day-to-day quality activities within a manufacturing environment.
- Exhibit a sense of urgency to address and resolve multiple quality issues promptly.
- Validate processes, review product validation efforts, and support product development and production transfers.
- Act as part of the Value Stream Team for Lean initiatives, contributing to Lean Manufacturing and 5S processes.
- Establish and maintain metrology and calibration programs.
- Support problem-solving efforts for in-process and vendor-related quality events.
- Conduct supplier approval assessments per Approved Supplier List (ASL) requirements.
- Translate product requirements into inspection criteria and process capabilities.
- Support QMS internal audits and supplier/customer site audits.
- Provide program launch support at company and customer facilities.
Job Requirements
Qualifications
- Bachelor’s degree in Engineering (Mechanical, Materials, or Industrial) with 5+ years of quality or manufacturing experience in a regulated industry (Medical Device or Pharmaceutical).
- Certified Quality Engineer (CQE) with 10+ years of relevant experience will be considered.
- In-depth knowledge of ISO 13485 and 21 CFR Part 820.
- Strong understanding of statistical process control and process capability.
- Cleanroom experience is required.
- Ability to make decisions independently, provide direction to quality inspectors, and execute quality processes effectively.
- Exceptional multitasking skills and the ability to thrive in a fast-paced environment.
What We Offer
- A collaborative and innovative work environment.
- Opportunities to drive meaningful contributions in Lean Manufacturing and continuous improvement initiatives.
- Professional development and growth opportunities within a regulated industry.
If you are a detail-oriented and solutions-driven professional with a passion for quality and compliance, we encourage you to apply for this exciting opportunity to join our team!
Additional Information
At HW Staffing Solutions we recognize the value of our employee associates as equally as our clients. We are passionate about people and improving the lives of every associate, we do this by connecting you with great companies and great opportunities. We celebrate our awesome diversity, believe that everyone has a unique talent, and appreciate the passion and perspectives that each of us bring to the table. Discover a new way to work together with a company that is focused on offering the best opportunities, benefits and career advancement in Accounting & Finance, Office & Administrative, Light Industrial, Professional & Technical, Call Center, Food Processing and Hospitality. HW Staffing Solutions is an Equal Employment Opportunity company.
Meet Your Recruiter

Velma Blevins
Staffing Specialist
Hi,
My name is Velma and I love to connect Awesome people with Great Companies. Please contact me at 207.239.3752