Sr. Process Quality Engineer

Rochester, NY
June 05 2017
Position Type
Full Time
Job Description
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.

What You'll Get to Do:

As a Senior Quality Engineer you'll be a key member of the Value Stream and will work to continuously improve quality and drive cost savings.

Make an impact working at a company that is a leader in serving science. Our products and customers are those which go on to change people's lives.

How You'll Do It:

You'll be responsible for assuring manufacturing processes are in compliance with Thermo Fisher Scientific ISO/cGMP Quality Management System to produce consistent quality product. The Process Quality Engineer is also responsible for identifying opportunities and drives improvement and reduces variation in our manufacturing processes
    Process validation of molds, equipment, and processesDetermine need for validation of new or changes to molds, equipment or processesWork with Engineering on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectivenessProcess Validation IQ, OQ, PQ close-out review, justification, and approvalCorrective and Preventive Action
      Review non-conformance and other manufacturing metrics to identify CAPA opportunitiesFacilitate 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 actionsParticipate in PPI Team to support continuous improvementAnalyze process capability data and other quality metrics in order to propose specification or process changes to Engineering
    Quality representative on process change projects
      Use risk management tools (pFMEA) to evaluate impact of changeEnsure product verification and process validation requirements are reviewed and defined appropriately
    Support Quality Control inspection
      Ensure the accuracy and adequacy of quality control inspection plans (QCIP's) and standard test procedures (STP's) for purchased and manufactured components and finished goods to meet the latest quality and system specificationsCommunication of QCIP and STP additions and changes to Quality Control Department in a timely, efficient and practical mannerResearch, recommend and implement new and improved gauging, measurement and data acquisition systems to improve inspection efficiency and repeatability and reproducibility of measurement systems
    Other duties as assigned

Minimum Requirements/Qualifications

    Position requires a Bachelor's of Science Degree in Engineering or equivalent experience, and minimum 7 years direct Quality Engineering experience.Lean / Six Sigma experience, Black Belt is a plus.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, 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 a plus.
    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 55,000 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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