Quality Manager

Our client is a recognized world leader in their field making devices used at home and by healthcare professionals all over the globe. They are currently seeking a Quality Manager to join their growing team.

Responsibilities will include:

• Centrally responsible for maintaining and enhancing compliance for quality system certifications and quality processes.
• Oversee the scheduling, performance and responses to internal and external audits.
• Manages the company CAPA system.
• Work cross-functionally in continuous improvement and product cost reductions.
• Lead Management Review meetings.
• Oversee, maintain, and create 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:

• Minimum of 5+ years as a manager of Quality or Quality Assurance at a medical manufacturing company with an appreciation for the requirement of meeting customer delivery requirements.
• Knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485 versions, Australian regulations and the EU Medical Device Regulations. They will be required to be ISO Management Representative and MDR Qualified Person and previous experience in these roles desired
• 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.
• Required education: Bachelor’s in Engineering.

Tagged as: CAPA, continuous improvement, FDA, inspection, ISO, manufacturing, medical device