Quality Manager (Med Dev)

This is an exciting opportunity to join a fast growth med device company with disruptive technology that has proven key to reducing infection and life-threatening complications for a huge subset of hospitalized patients. With FDA approved products on the market, a strong financial outlook and a robust pipeline, our client is now ready to expand their suite of offerings.

You will be responsible for leading the manufacturing Quality group. This is a collaborative position working closely with Operations to support production management and production initiatives while ensuring compliance.

Responsibilities

• Lead the manufacturing Quality group of Quality engineers and Quality Control technicians (a team of 4).

• Quality System owner of Nonconformances (NCR), Corrective and Preventive Action (CAPA), Customer Complaints, and Change Control among other systems.

• Responsible for Medical Device Reporting (MDR) to the FDA.

• Responsible for the environmental monitoring program.

• Oversee the equipment control and calibration programs.

• Manage incoming inspection.

• Identify and lead continuous improvement activities to enhance Quality Systems and manufacturing processes.

• Support the internal audit program.

• Be a hands-on contributor within the manufacturing Quality team when needed.

Requirements

• BS in related technical field, preferably Engineering

• 8+ years of Quality experience in the Life Science or Medical Device Industries

• Managerial experience

• Self-initiator with strong organization skills

• Teamwork, flexibility and adaptability to change

• Ability to communicate and lead through influence