Quality Assurance Associate - Medical Device - MN

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.

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 - $120,000+ (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