Quality Assurance Specialist

Quality Assurance Specialist - Build Your Career in Medical Device Innovation

Are you detail-oriented, organized, and passionate about ensuring quality at every stage of production? A growing medical device manufacturer in Chanhassen, MN, is seeking a Quality Assurance Specialist to join their team. This is a direct-hire opportunity to work with a company that's making a difference in healthcare through cutting-edge technology and high-quality solutions.

Hours & Pay

Pay: $35.00 - $40.00 per hour (depending on experience)

Schedule: Monday - Friday, 8:00 AM - 4:30 PM

Type: Direct Hire

Level: Non-entry level (2-3 years of quality experience required)

Why You'll Want This Role

In this position, you'll be at the heart of quality assurance for a respected medical device organization. You'll enjoy a competitive salary ($35-$40 per hour, depending on experience), a consistent weekday schedule, and the security of a direct-hire role. Beyond compensation, this company offers a comprehensive benefits package, career advancement opportunities, and the chance to grow your skills in FDA, ISO, and global medical device compliance. You'll be part of a supportive team that values accuracy, innovation, and continuous improvement!

What You'll Do

• Perform quality assurance tasks to ensure products, processes, and documentation meet the highest standards.
• Maintain compliance with FDA, ISO:13485, MDSAP, and MDR regulations.
• Collaborate with Engineering and Quality departments during product development to ensure compliance throughout the design and manufacturing process.
• Prepare and manage product registration documentation.
• Perform post-market surveillance and support manufacturing risk management activities.
• Assist with internal and third-party audits in partnership with Regulatory Affairs.
• Conduct complaint investigations and complete related documentation.
• Support CAPA (Corrective and Preventive Action) processes.
• Analyze and monitor quality data to drive continuous improvement and support Site Management Reviews.
• Provide leadership and support on development projects to ensure timely market clearance submissions.

What You'll Bring

• Bachelor's degree in Medical Device, Engineering, or related field.
• 2-3 years of quality experience in the medical device industry.
• Solid understanding of medical device regulations (ISO:13485, FDA, MDSAP, MDR).
• Excellent attention to detail, organizational skills, and analytical ability.
• Strong communication and time management skills.
• Proficiency with Microsoft Office Suite and Adobe.
• Ability to work independently and collaboratively to meet deadlines.

Take the Next Step

If you're ready to take your quality expertise to the next level and grow within a company that's making an impact in healthcare, this is the opportunity for you.

Click "Apply Now" to join as a Quality Assurance Specialist in Chanhassen, MN!

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