Quality Manager

Responsibilities: 

• Maintaining compliance status of the company with respect to quality system certifications to ISO 13485:2016.
• Maintaining and enhancing processes to ensure quality system compliance with the FDA Quality System Regulation.
• Will be the ISO Management Representative and MDR Person.
• Oversees the scheduling, performance and responses to internal and external audits.
• Manages the company CAPA system.
• Leading Management Review meetings.
• Overseeing, maintaining, and creating Quality System documentation and regulatory files.
• Reviewing and approving validation activities.
• Leading Incoming Inspection, Document Control and Supplier Quality functions.

Qualifications / Experience Requirements

• Minimum of 5 years as a manager of QA/RA at a medical manufacturing company.
• Working knowledge of FDA Quality Systems Regulation and other countries may be necessary.
• Experience with specific devices containing hardware and software components.
• Excellent communication, interpersonal, time management, and leadership skills.
• We require someone willing to roll up their sleeves to get things done and not merely to pontificate and/or to direct the actions of others.
• Bachelor's Degree in Engineering.