Quality Engineer - CAPA

Posted 6 days 4 hours ago by OLYMPUS EUROPA SE & CO. KG

Permanent
Not Specified
Other
Devon, Plymouth, United Kingdom, PL1 1
Job Description

In this Quality Engineer position, you will act as a subject matter expert (SME) within the CAPA process, providing assistance and guidance to CAPA initiators and owners.

Your responsibilities
  • Responding to emerging quality issues, containment issues, and verification of products or materials that do not meet required standards and/or specifications.
  • Manage CAPA processes, including documenting all required information in the system.
  • Monitor CAPA phases to ensure timeliness in execution and inform management of potential risks of delays.
  • Ensure execution of all CAPA tasks and appropriate capture of objective evidence.
  • Manage product and process control.
  • Participate in problem-solving and continuous improvement activities, leading when required.
  • Generate and maintain control plans and inspection instructions.
  • Provide guidance and assistance with NPI design verification and validation processes.
  • Review and approve technical documents and process documentation.
  • Support and lead audit activities, including creating, conducting, and logging audits.
Qualifications
  • Demonstrable minimum of a HNC or higher in Engineering or Scientific discipline.
  • At least three years' experience in a Quality Engineering role within a highly regulated manufacturing environment.
  • Solid understanding of quality management systems, testing tools, and statistical analysis.
  • Strong collaborative skills and ability to work cross-functionally.
  • Effective interpersonal and communication skills.
  • Proven project management, problem-solving, critical thinking, and conflict resolution skills.
Core Values
  • Patient Focus - Putting patients at the heart of everything.
  • Integrity - Doing the right thing.
  • Innovation - Seeking new ways to improve.
  • Impact - Taking accountability and delivering results.
  • Empathy - Caring for one another and fostering teamwork.
Benefits
  • Generous annual leave, increasing with service.
  • Health care plans and additional support.
  • Company pension scheme.
  • Life assurance.
  • Discounted gym and wellness memberships, cashback, and retail discounts.
Further information

We value diversity, inclusion, and mutual respect. Our inclusive environment encourages everyone to contribute and thrive. We welcome applications from all talents eager to join Olympus.