Quality Engineer

Our client is a leading Medical Device company based in the North West, UK. At present, they are seeking a Quality Engineer or a permanent basis at their facility in the North West. Ideal candidates will be degree qualified in Engineering or Science related subject and will have previous Quality Engineering experience, ideally from Medical Device, Biotech or Pharmaceutical related industries.

Ideal candidates must have a working knowledge of and experience in developing and manufacturing product in a regulated environment, preferably medical devices to the requirements of cGMP, CFR 21 Part 820, MDD 93/42/EEC, ISO 13458 and ISO 9001.

The role responsibilities include;

Develop, generate and maintain documentation to support an effective and compliant Quality Management System, including:

· Product and Process FMEAs / Risk Assessments

· Medical Device Risk Management Reports and Files

· Quality Inspection Procedures and Control Plans

· Sampling Plans

· Material and Product Specifications

· Process Flow Charts

· Quality Systems and Process SOPs and Work Instructions

· Rapid investigation and resolution of customer reported quality issues.

· Initiate, track, report and trend non-conformities.

· Root cause analysis and problem solving for identified nonconformities and facilitate implementation

of actions to increase efficiency and further enhance product reliability.

· Conduct supplier audits, monitor and measure supplier performance when required.

· Provide quality input to new product developments and extensions to existing product lines,

identifying product and process CTQ attributes.

· Review and approval of validation deliverables.

· Participate in external audits from Customers and Regulatory Agencies.

· Conduct, report and track internal quality audits.

· Develop and deliver GMP and Quality Systems training programs.

· Comply with and promote health and safety policies in the workplace.

· Establish and maintain strong and effective internal and external customer relationships.

· Work effectively with colleagues to participate and contribute to the successful completion of

personal, team and business goals and objectives.

· Maintain an understanding of current Medical Device standards, directives and regulations.

· Monitor, measure and analyse data including product and process capability, to identify process and

Quality Management System deficiencies and continuous improvement opportunities.

· Represent the Quality Department at on site and off site meetings as required.

· Supervise Quality staff as required.