Job Description

We are a manufacturer of orthopedic components and materials manufactured to high specifications for the medical industry. Our main focus is to supplying high quality medical products to exacting customer and international specifications, supported by our Technical Department which is capable of testing polymeric materials to the highest standards. In order to support continued business growth, we require an enthusiastic individual to join our business to work within our Quality Department.

Key Accountable Areas:

Determine the correct approach/next steps using risk-based decision making. Support and mentor Quality controllers and Quality Inspectors Author and review RCA (root cause analysis) and CAPA records. Provide training to employees in carrying out RCA Lead process improvement activities Support and lead validation activities Design and set-up gauge R&R, equivalency and process capability studies Present metrics and data on a routine basis to colleagues, peers and management Interpret and ensure adherence to customer requirements Research and assess new technologies to drive process improvement with Quality Author and approve QMS documentation Ensuring processes needed for the QMS are established, implemented and maintained Support NPI projects as required Liaise with customers and be the point of escalation for any customer issues Conduct 1:1 meetings with team members and perform other personnel meetings as required, e.g. probation reviews Creating, completing and reviewing engineering change notes/change controls Creating PFMEA's and conducting risk assessments Liaising with all functions (including suppliers) Process evaluation and improvement - fault root cause investigation and process controls implementation Analyse data by completing hypothesis, normal distribution, and process capability analysis tests Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence Prepares reports by collecting, analysing, and summarising data; making recommendations Lean manufacturing Ensure health and safety standards are adhered to Ensure that all products are thoroughly quality checked Ensuring promotion of awareness of regulatory and customer requirements throughout the company Conduct internal and supplier audits Support and mentor Quality Controllers and Quality Inspectors Develops sampling plans by applying attribute, variable, and sequential sampling methods Responsible for training and development of Quality Controllers Coordinate the implementation of new quality standards Ensure that Client, Supplier and Internal Audits are carried out to the defined schedule

This Exciting Position Requires a Person Who Is:

Methodical and meticulous in approach An effective communicator and a good team player Conscientious and has a self-disciplined approach Motivated and flexible in their approach Ability to self-manage as well as working as part of a team Excellent time management and multi tasking skills Capable of producing high quality written material by hand Computer literate

Required Qualifications/Knowledge:

Quality or Mechanical Engineering related qualifications (ONC/HNC/Degree) or equivalent qualifications Quality Management System Principles and Techniques International & British Quality Standards (ISO 9001, ISO 13485, ISO 17025, ISO 14001, ISO 45001, FDA, QSR's and Medical Devices Directive) Good Manufacturing Practice Quality toolbox including FMEA, Process flows, Root cause investigations, Lean and Six Sigma tools & techniques Interpretation of complex technical drawings Internal Audit experience to the relevant standards MSA & GR&R experience Document and maintain records accurately Process Validation Experience within a Quality process related role Medical / automotive background Root cause analysis and problem solving

Hours of Employment

Monday to Thursday 08.30 - 17.00, Friday 08.30-13.30 (35 hour working week), which includes breaks. Duties and hours may vary dependent upon workload
Please forward your CV & salary expectations

Job Type: Full-time

Pay: 35,000.00-41,000.00 per year

Benefits:

Company pension Cycle to work scheme Employee discount Health & wellbeing programme On-site parking
Application question(s):

Number of years Quality Engineering experience Please advise the industry in which you gained your Quality Engineering experience Are you familiar with, and fully understand engineering drawings and tolerance requirements and tolerance requirements? Notice period required
Education:

Diploma of Higher Education (preferred)
Work Location: In person