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For your reference, we have included the original job posting below.
Process Control Engineer
Job Number:
42019391
Company Name:
Stryker Corporation
Job Location:
Phoenix, AZ US
Job Categories:
Manufacturing & Production Engineering & Architecture
Process Control Engineer
The Process Control Engineer is responsible for supporting and conducting equipment validation and gauge R&R studies related to new product introduction (design transfer), process improvements, and any other changes related to the manufacturing environment. The Process Control Engineer is also responsible for assuring the quality and integrity of medical devices through testing, validation and analysis of results.
Qualifications/Work Experience
-Participate on technical project teams as subject matter expert on equipment validation regulations/procedures;
-Specify appropriate qualification methodology for specific projects and applications;
-Participate in project planning, scheduling, and tracking;
-Develop validation master plans and strategies for new and modified manufacturing processes;
-Lead and/or provide guidance on the development, writing, execution, and analysis of protocols and reports for equipment validation;
-Support Design for Manufacturing review of new products;
-Support process development through review and approval of process specifications;
-Support internal and external audits and CAPA execution as needed;
-Support the Quality department as required;
-The preceding duties and responsibilities are intended to be representative of the work and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position (i.e. overall support of the quality department as required).
QUALIFICATIONS: -Strong technical writing and interpersonal skills;
-Demonstrated results orientation, multi-tasker, quick learner, team player with the ability to respond quickly to urgent needs;
-Applied technical understanding of manufacturing equipment and processes specific to medical device manufacturing;
-Proven ability to provide consistent Quality-driven leadership in validation activities;
-Knowledge and experience of quality tools related to Failure Modes Effect Analysis (FMEA), SPC, root cause analysis, Gauge R&R, and process mapping preferred;
-Bachelor's Degree (B.S.) or Master's Degree (M.S.) from four-year college or university in an engineering discipline; candidates with a B.S./M.S in Biomedical, Mechanical, or Chemical Engineering are preferred;
-2 years experience in process/system/equipment validation;
-Strong working knowledge of FDA/QSR, ISO 13485:2003, Quality Engineering principles, and quality tools and methods.
