Quality Assurance Manager - Medical Device

Eurofins Scientific is seeking a Quality Assurance Manager to lead the Quality Assurance Department within our medical device division. This role is integral to ensuring compliance with regulatory standards and maintaining the highest quality in our laboratory operations. The successful candidate will oversee quality operations, manage client and agency audits, and uphold our certifications and accreditations.

Key responsibilities include managing QA, QC, regulatory, and compliance activities to achieve quality and business goals, monitoring quality management systems for trends and improvements, implementing training programs to meet regulatory requirements, and maintaining current records for required certifications. Additionally, the role involves effective communication with clients and agency auditors, responding to findings, and addressing concerns promptly.

The ideal candidate will possess a Bachelor's or Master's degree in a scientific field, with at least five years of experience in the medical device or biopharmaceutical industry, including data review responsibilities and a working knowledge of regulatory requirements. A solid understanding of chemistry and laboratory practices, knowledge of auditing techniques, and strong leadership and communication skills are essential.

This full-time position offers a competitive salary ranging from $80,000 to $100,000 annually, along with comprehensive benefits including medical coverage, life and disability insurance, 401(k) with company match, paid holidays, and paid time off.

Eurofins Scientific provides a dynamic and collaborative work environment with opportunities for professional growth. Our commitment to quality and innovation makes this an excellent opportunity for individuals looking to advance their careers in quality assurance within the medical device industry.