Overview
Quality Assurance Associate Medical Device
My medical device client is an innovative company that develops and manufactures regenerative therapies for patients. They are seeking to hire a Quality Assurance Associate responsible for supporting new and existing product development efforts ensuring compliance with all required standards including ISO and GMP.
Role must report to the office daily in Minneapolis, MN.
Responsibilities :
- In alignment with regulatory requirements, support creating, maintaining and implementing processes and procedures
- Support and monitor sterilization, validation, risk management and design standards
- Collaborate with team in Quality practices, procedures and decision making
- Manage product return procedures and related training
- Handle customer complaint resolutions and documentation
- Oversee vendor audits
- Maintain knowledge of the organization’s critical quality requirements
Requirements :
- Bachelor’s Degree
- Min. 5+ years of Quality Assurance experience within Medical Device
- Prefer certification as Certified Quality Engineer (CQE), ASQ certification and / or related certifications
- Knowledge / understanding of FDA, ISO 14971, cGMP ISO 13485
- Ability to multi-task and prioritize projects, meet deadlines
- Excellent analytical and problem-solving skills
- Strong communication and presentation skills
- Statistical / Data analysis and report writing skills
- Proficient in Microsoft Office suite
Offering :
- Base Salary $90,000 $100,000 (based on experience)
- Benefits Package
Direct Sales Recruiting, LLC, (DSR) and DirectHR are National Recruitment organizations partnering with National, Regional and Local Clients to bring qualified candidates a career and a future.
DSR offers over 50 years combined Recruitment, Sales and Management experience. We are, along with our clients, an Equal Opportunity Employer and are committed to hiring and supporting a diverse workforce. A M / F / D / V
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