Quality Assurance Manager

I am recruiting Quality Assurance Manager for a medical company, this is influential position reporting to the CEO. The role involves managing the quality assurance department in the company, leading a team of over 12 employees, and managing an additional company factory abroad.

Your Responsibilities:

• Lead quality improvement implementation as appropriate to legacy products, continuous improvement, and customer satisfaction.
• Responsible for the development, maintenance, and continuous improvement of Quality KPIs.
• Receive assignments in the form of strategic objectives and determine how to use resources to meet schedules and goals. Tracks assignments status, quality, and report-out to management
• Manage and Monitor Quality Transition plans and activities.
• Handling external audits by notified bodies, auditing organizations, and regulatory authorities
• Plan and manage implementation of internal quality audits and related findings
• Overview of training planning and effectiveness
• Formulate and recommend (changes to) policies and established procedures that affect immediate organization(s) activity, either directly or through Q&R functions.

You're the right fit if:

• BSc in Engineering or Practical Engineering with Qualification in Quality Assurance (CQE, CQM or CQA).
• At least 3 years of experience in QA/QMS management at a Medical Device Company
• Proven experience in the establishment and / or management of quality systems in compliance with ISO 13485, preferably for a multi-disciplinary product.
• Proven experience in leading MDSAP / ISO 13485 audits/ FDA-QSR Inspections
• Great communication and influential skills, Supportive and service-oriented, Team Player
• Fluent in verbal and written English.