Job Title: QA Engineer III
Requisition ID: 53317BR
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Under the direction of the Sr. Manager Quality Assurance, the Quality Engineer is responsible for assuring manufacturing processes are in compliance with Thermo Fisher Scientific ISO/cGMP Quality Management System to produce consistent quality product. The Value Stream Quality Engineer is also responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes resulting in improved metrics
Corrective and Preventive Action and other Continuous Improvement Activities:
- Review non-conformance and other manufacturing metrics to identify CAPA opportunities
- Facilitate CAPA investigations for customer complaints, recurring NCR’s, audit non-conformances, and other investigations using problem solving standard work to identify root cause and implement effective corrective actions
- Analyze process capability data and other quality metrics in order to propose specification or process changes to Engineering
- Participate in PPI (Practical Process Improvement) and projects to support achievement of business metrics (OEE, LIFR, Past Due, Scrap and other cost savings).
- Document non-conformance found in the assigned value stream
- Work with production to resolve non-conformances and recommend actions to prevent recurrence
- Verify the effectiveness of actions take
- Customer Complaint Support
- Investigate customer complaints
- With the support of the personnel in the affected Value Stream determine containment, root cause, correction, corrective action.
- Verify effectiveness of actions taken
- Determine need for validation of new or changes to methods and equipment
- Support Engineering on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness
- Process Validation IQ, OQ, PQ close-out review, justification, and approval
- Quality representative on process changes for the assigned Value Streams
- Use risk management tools to evaluate impact of change
- Ensure product verification and process validation requirements are reviewed and defined appropriately
- Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience, and 5 to 7 years direct Quality Engineering experience.
- Disciplined problem solving capability: Lean / Six Sigma, Shainin, etc.
- Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485 is a plus.
- Working knowledge of Excel, Word, Access, Minitab, quality software, and statistical methods (SPC, DOE, Gauge R&R etc.) and risk management techniques (dFMEA/pFMEA).
- Project planning and advanced computer skills a plus.
- Plastic product manufacturing experience is required.
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
- Leadership Skills: Proven ability to influence others and lead significant change.
- Strong communication skills both written and verbal
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
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