Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Head of QA and RA

Europlaz is seeking to hire a Head of Quality Assurance and Regulatory Affairs. This is a key role within the company reporting directly to the CEO with an opportunity to have a real impact on the company’s development and culture. The organisation is undergoing significant growth so it is a great time to join and be part of the success of this company. We successfully completed our transition audit to ISO13485:2016 in February 2018, new certificates will be issued in April 2018.

Key Responsibilities

  • Responsible for Regulatory Affairs and Quality Management administration and for significant contributions to the formulation, development, implementation, and administration of Company policies and business goals.
  • Organises, plans, directs, and controls all Regulatory Affairs and Quality Management functions including product registration, complaint handling and reporting, critical process management e.g. sterilisation, internal and external auditing of the quality systems and supports R&D.
  • Develops policies, procedures, and training to ensure efficient and effective operation of the Company quality system and regulatory requirements.
  • Manages the complete quality team and quality culture throughout, ensuring services are professionally delivered and customers well served.
  • Serves as the Quality System Management Representative and primary company representative to the FDA and to all Competent Authorities.
  • Responsible for company compliance activities related to US FDA, ISO, and all relevant regulatory requirements.


Skills Required

  • significant experience in medical device Quality Assurance
  • Cleanroom manufacturing –cleanroom assembly, packaging and terminal sterilisation experience
  • Sterilisation outsourcing and microbiology experience beneficial 
  • Fully conversant with FDA, MDR requirements
  • Proven background in leading teams and driving change throughout an organisation 
  • Strong line management experience 
  • Extensive ISO 13485: 2016 knowledge 
  • Project management experience would be useful 
  • Lean manufacturing principles 
  • Proven ability to work in a cross functioning medical device manufacturing environment