Quality Engineer

Job Description

Smith + Nephewis a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform attheir fullest potential.From our first employee and founder, T.J. Smith, to our team today, its our people who make Smith+Nephew a unique place.Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But its our culture - of Care, Collaboration and Courage - that really sets us apart.Through a spirit of ownership and can-do attitude, we work together to win.Were a company of people who care about each other, about our customers and their patients, and about our communities.ROLE OVERVIEWResponsible for maintaining the quality management system procedures for the Leamington Spa facility. Administer Leamington Spa quality management system and corrective and preventive action system. Leading production projects, supporting validation andchange management.ESSENTIAL FUNCTIONS

• Provide Quality Engineering support for production projects, leading validation activity & change management. (20% of role)
• Provide Quality Engineering support to production for process improvement projects. (20% of role)
• Assist in the management of the CAPA system, Lead the investigation of non- conformances, and lead the CAPA plan for timely closure (20% of role)
• Lead the development and evaluation of Statistical Process control within the manufacturing facility (10% of role)
• Create and maintain metrology programs for a range of precision metrology equipment Surface Finish Analyzer, Air Gages and inspection techniques such as, Roundness Testing,and coordinate measuring machines (CMMs) 10%
• ESSENTIAL FUNCTIONS
  • Provide Quality Engineering support for production projects, leading validation activity & change management. (20% of role)
  • Provide Quality Engineering support to production for process improvement projects. (20% of role)
  • Assist in the management of the CAPA system, Lead the investigation of non- conformances, and lead the CAPA plan for timely closure (20% of role)
  • Lead the development and evaluation of Statistical Process control within the manufacturing facility (10% of role)
  • Create and maintain metrology programs for a range of precision metrology equipment Surface Finish Analyzer, Air Gages and inspection techniques such as, Roundness Testing, and coordinate measuring machines (CMMs) 10%
  • Monitor CER using calibrated gauging as per procedural requirements 5%
  • Control the gauge calibration system in both completing internal gauge calibration and arranging external calibration 5%
  • Performs and documents First Article Inspections Requirements (FAIR) on new products or after changes to a process 5%
  • Engineering Dept External Relationships Key suppliers Organization Influence Quality Department Limits of Authority Reports direct to line manager
  • Monitor CER using calibrated gauging as per procedural requirements 5%
  • Control the gauge calibration system in both completing internal gauge calibration and arranging external calibration 5%
  • Performs and documents First Article Inspections Requirements (FAIR) on new products or after changes to a process 5%
  • Engineering Dept External Relationships Key suppliers Organization Influence Quality Department Limits of Authority Reports direct to line manager

REQUIREMENTS

• Travel Domestic 10%; International - Rarely

EDUCATION

• Bachelors degree in engineering

Licenses/CertificationsProven experience in project management, leading Validation projects in a high technology low volume manufacturing environment Skilled in Process and equipment Validation (eg. FAT, SAT, IQ, OQ and PQ) Lean and Six Sigma knowledge beneficial.ExperienceMinimum 4 years experience in Medical Devices, regulatory affairs/compliance. ISO13485, FDA Competencies Communication, assimilation of data, working relationships across divisions. Other Ability to use MS Project, Word, Excel SCOPE Budget N/A