Quality Manager

We have over 60 years’ experience as a leading manufacturer of medical devices and specialist healthcare products.

We offer employer sponsored health plans. Corporate paid life and disability insurance. 401k Match up to 5% with 3 year vesting period. Education reimbursement and employee discount program.

Your Role:

• Plan, direct, or coordinate quality assurance programs and production activities for our medical device and commercial machining divisions
• Ensure compliance with regulatory processes, such as internal audits, inspections, license renewals, or registrations
• Schedule and lead all external and internal ISO 13485, ISO 9001, and AS9100 audits
• May compile and prepare materials for submission to regulatory agencies
• Establishing, maintaining, and improving the Quality Management System; directing work of others
• Responsible for Metrology Lab – all equipment and processes including CMM & Laser Tracker programming/operation, document control, and departmental metric
• Hiring, developing, and performance management of a team of quality professionals

Education/ Experience:

• Bachelor’s Degree in Manufacturing, Technical, Science, or Engineering discipline and at least one year of professional experience in regulatory affairs or in quality management systems; OR four years of professional experience in regulatory affairs or in quality management systems position, preferably relating to medical devices.
• Track record of success leading teams through regulatory audits for ISO 13485, ISO 9001 and AS9100 Rev.D
• Knowledge of FDA submission and approval process
• Proficient with Microsoft Office Suite
• Experience with MRP system, preferably SAP; ProShop
• Working knowledge of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485;2016, ISO14971, European Medical Device Directive [MDD], new Medical Device Regulation [MDR], and FDA GMP

Personal Qualifications:

• Entrepreneurial spirit
• Quality mindset
• Independent & Self-Sufficient leader
• Highly organized and detail oriented
• Dynamic/flexible personality
• Excellent verbal and written communication skills capable of interacting with a variety of audiences and professions

Must be a U.S. citizen or national, U.S. permanent resident (current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.