Kelly Engineering Resources
Clinton, Massachusetts, United States
Job type: fulltime
Job industry: Other
Client in Clinton, MA, one of the leading global players in the drug delivery device, is currently hiring a Quality Engineer. The Quality Engineer will be a Contract role without an end date. Summary:
Ensure quality requirements are met per customer specifications through statistical analysis and proactive problem solving using current lean/six sigma tools, processes and systems ensuring effective root cause determination and corrective action. Essential Functions include:
Support IQ-OP-PQ validation with (GD&T, Cpk, SPC, t-tests, OC Curves, sample size, Minitab).
Interfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met.
Use statistics to assess product performance data solve and complex manufacturing quality problems.
Investigate of out of specification product dimensions to determine impact to released product to include: 1) Leading & performing full CAPA process from containment to corrective action to prevent recurrence, writing technical reports in support of NCMR investigations and CAPA, and managing MRB product dispositions. Required Qualifications, Skills and Abilities include:
Injection molding experience.
Experience in a quality/regulatory environment; FDA 21CFR80.820, ISO13485.
Clear and concise verbal, written skills including to external customers.
Clear and concise presentation of data to groups including customers, leadership and sales.
Demonstrated application of structured problem-solving methods and tools.
Demonstrable application of project planning & management.
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