The Quality Manager is an Exempt/Full-Time role overseeing and managing all department activities within the Quality Assurance department. The Quality Manager would work among a diverse team of experts, itself, part of a highly skilled multidisciplinary team dedicated to achieving the successful commercial launch of a medical device and development of next-generation technologies.

● Oversee and manage all department activities within the Quality Assurance Department

● Maintain knowledge of quality standards and regulations, including proposed and final rules

● Lead external audits/inspections (preparation, execution, and responses)

● Ensure that quality management system requirements are effectively established and maintained

● Enforce compliance with regulatory requirements through internal and external auditing and maintain evidentiary records by supporting procedure development, implementation, and reviews appropriate to the organization

● Collect, analyze, and trend quality data

● Ensure robust investigations and solutions are developed as part of the Quality Systems processes

● Act as Quality Approver for quality records and final release of product

● Manage customer complaint files to ensure global regulatory compliance including the review for possible adverse events and MDR

● Manage CAPA (corrective and preventive action) and focus on continuous improvement and customer satisfaction

● Evaluate, monitor, and audit vendors

● Review and approve supplier’s documentation and records (e.g., quality plans, process validations, etc.)

● Ensure that team members are trained to the organization’s processes and necessary standards

● Ensure that audits of the quality system are performed in an efficient, timely and complete manner

● Report to top management on the performance of the quality management system and ensure the promotion of awareness of regulatory requirements throughout the organization.

● Participate in design reviews for new products

● Develop and approve appropriate inspection plans

● Ensure compliance to design control activities in support of new projects/products

● Control and maintain quality records

● Additional duties as assigned.

• B.S. Degree or higher in science, engineering, or technical discipline

• 5+ years of quality management experience working with medical devices (preferably class II and class III)

• Strong knowledge of ISO13485, 21 CFR Part 820, EU MDR 2017/745, and MDSAP

• Strong leadership and communication skills, and the ability to work within cross-functional project teams

• Detail oriented, hands-on manager

• Experience with new product development or engineering highly preferred

• Strength in data analysis, trending, and forecasting of numbers

• Familiarity with EO sterilization process and validation requirements

• Experience with sterile single use medical devices

• Demonstrated ability to work on complex problems and business processes in which the analysis of situations and/or data frequently requires an in-depth evaluation of multiple, interdependent factors and professional judgment

• Ability and interest in “rolling up sleeves” to perform “hands-on” quality

• Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision

• Ability to work efficiently on multiple tasks with deadlines in a small company where job duties/priorities may change

• Ability to work in a diverse team with members of varying education and experience levels

• Lean, Six Sigma, ASQ or similar certification beneficial

• Creative/innovative, able to rapidly problem-solve and work well given typical project schedules

• Exposure to medical/clinical/surgical environment and knowledge of health care industry