Quality Manager

Our client, the recognized world technology leader in their niche medical device industry is seeking a Quality Manager to join their successful team.

Responsibilities will include:

• Maintains the compliance status of the company with respect to quality system certifications including ISO 13485 as well as global certifications for class 2 devices. Maintains and enhances processes to ensure quality system compliance with the FDA Quality System Regulations
• ISO Management Representative and MDR Qualified Person.
• Oversees the scheduling, performance and responses to internal and external audits.
• Manages the company CAPA system.
• Supports Management Team to accomplish product cost (COG) reduction and incremental profitability of the company without sacrificing quality and integrity of the product.
• Leads Management Review meetings.
• Oversees, maintains, and creates Quality System documentation and regulatory files.
• Participates in decision-making team relating to Medical Device Vigilance, MDR’s, product recalls and issuance of Advisory Notices, if required.
• Reviews and approves validation activities.
• Leads Incoming Inspection, Document Control and Supplier Quality functions.

Background profile:

• Required education: Bachelor’s in Engineering.
• Minimum of 3-5 years as a manager of QA/RA at a medical manufacturing company with an appreciation for the requirement of meeting customer delivery requirements.
• Working knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485 versions, Australian regulations and the EU Medical Device Regulations. Other countries may become necessary. Experience with MDSAP is beneficial.
• Experience with devices containing both hardware and software components.
• Experience with 21 CFR Part 11 Electronic Systems preferred.
• Excellent communication, interpersonal, time management, and leadership skills.
• Appropriate quality certifications preferred.

Tagged as: 13485, FDA, manufacturing, medical device, QA/RA