Quality Engineer in the Cluster Material & Surface Technology Development group. The role involves utilizing Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.
*Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes.
* Support Quality and Validation activities for product transfers and new product introductions.
* Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
* Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
* Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
* Determine process inputs and factors for variation where process capability is required.
* Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
* Develop pFMEA documentation to support processes as part of Validation process
* Partner with R&D and other cross-functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
* Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
* Support root cause analysis activities related to material processes.
* Communicate effectively with global functions and internal team on actions and deliverables.
* Provide timely and accurate reporting and management of escalations as appropriate on project activities.
* Ensure all activities comply with GMP, ISO and quality system requirements.
* Ensure that all health, safety and environmental requirements are fulfilled.
* BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment
* Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
* A thorough understanding of GMP/ISO and validation regulations.
* Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Problem-solving engineering expertise (Six Sigma, SE or A3)
* Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred
* Strong verbal and written communication skills
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