QUALITY ASSURANCE MANAGER

Quality is a Core Value within PuriCore. We are looking for a Quality Assurance Manager to join the team in our Stafford office. The organization includes an operations team comprised of project engineers, workshop engineers, field engineers as well as research and development team of microbiologists, chemists and technicians. The QA Manager will be responsible to drive a quality mindset and approach throughout the organization. This will be achieved by creating and implementing a quality plan, tracking quality metrics, providing employee training and giving daily input to the engineering and research and development initiatives. The position reports to the Director of Quality and Regulatory Affairs who is based in the US headquarters.

This position offers an individual the ability to function in a hands-on technical and process driven role while also assuming a leadership role in the organization driving quality. It represents an opportunity to be part of the management team, work with a well-regarded technology and interact with a wide variety of constituents, including customers, regulatory personnel and many other departments within the business. You will also enjoy a lot of autonomy, the opportunity for great influence and ownership for running the important Quality function.

Main Responsibilities:


  • Manage the UK Quality System by assuring that the appropriate procedures are in place, being followed consistently and are in compliance with the regulations such as ISO, HTM2030, Health and Safety, etc.
  • Assure all team members are trained to the Quality System.
  • Assure that the facility is properly prepared to pass ISO inspections.
  • Manage the Customer Complaint Handling System by assuring that all complaints are properly documented, processed in a timely manner, and appropriate corrective action are taken.
  • Manage the Corrective and Preventive Action (CAPA) process by reviewing trends and communicating status and improvement action to senior management team.
  • Coordinate quality related corrective actions with third party business partners.
  • Work with field service management to assure that machine performance at customer locations is optimized and design improvements identified are implemented timely.
  • Manage the Supplier Quality Assurance activities and audits.
  • Assure new products are introduced into the marketplace in accordance with Design Controls and that all products are properly validated.

Key Qualifications:


  • BS degree in Electrical or Mechanical Engineering.
  • Five or more years of Quality Engineering experience to include a minimum of 2 years medical device experience.
  • Ability to build strong relationships and demonstrated ability to influence and drive change and policy implementation within a business.
  • Experience in tracking and driving improvement in quality metrics through process or design changes.
  • Production QA (design) hands-on experience.
  • Supplier QA engineering hands-on experience, including audits.
  • Design control hands-on experience.
  • Knowledge of ISO9000, health and safety standards and HTM2030 preferred, ISO 9000 quality system implementation a plus.
  • Detail orientation and bias for action, along with self-starter working style.

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