Requisition ID: 21078BR
Job Title: Process Control Engineer
Division: Global Quality & Ops
Business Unit: Sustainability Solutions
Business Functions: Quality Assurance Safety
Business Sub-Functions: Production Quality Assurance
Country: United States
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 responsible for assuring the quality and integrity of medical devices through testing, validation and analysis of results.
DUTIES & RESPONSIBILITIES:
EDUCATION & 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 validations.
- Support Design for Manufacturing review of new products.
- Support process development through review and approval of process specifications.
- Conduct system and process audits of internal and external resources.
- Support CAPA execution as needed.
- The preceding duties and responsibilities are intended to be representative of the work and are not all-inclusive.
Percent Travel Required: 0%
- 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.
- 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.
- ASQ Certification (e.g. CQE, CMQ/OE, CSSGB, CSSBB) preferred.
- Strong technical writing and interpersonal skills.
- Microsoft Office (e.g. Word, Excel, PowerPoint, Outlook).
- Statistical software (e.g. MiniTab).
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare...