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Job Details
Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com Senior Quality Engineer Stryker is hiring a Senior Quality Engineer in Cary, IL. This Engineer will provide support and direction in quality assurance, control and preventative activities with a focus on sustaining products. Manages the execution and changes in quality activities for internal and external suppliers related to process development, verification, validation and manufacturing transfer while ensuring compliance to regulations and standards. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards. Who we want:
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Maintains KPIs for monitoring of process and/or product quality, performs analysis, and interprets trends. Proactively lead process improvements.
- Works closely with operations and the business functions to ensure quality performance of product and processes and performs/leads GEMBA walks for continuous improvement.
- Participate in the development of basic systems by translating manufacturing and quality requirements into robust processes
- Leads internal and external audits by regulatory agencies, notified bodies, competent authorities, etc with subject matter expertise.
- Participates in the development and review of process and equipment validation/qualification and MSAs.
- Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
- Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes.
- Mentor and Influence others in root cause/problem solving efforts, including advanced troubleshooting and events of increasing complexity.
- Bachelors Degree in a Science or Engineering discipline
- 2+ years of working experience in engineering, quality, manufacturing, pharmaceuticals or regulatory environments.
- Validation certified engineer
- Electronic validation experience
- Automation background
- Valgenesis experience
- Oral Care Medical Device experience
- ASQ Certified Quality Engineer or similar certification
- Proficient understanding of Pharmaceutical / Medical Device manufacturing processes, FDA CFR 210, 211, and 820, ISO 13485, ICH Q7/Q10
- Lean Six Sigma/Investigation (CAPA) training
- High level knowledge/experience of risk based and statistical techniques; process risk, statistical sampling plans, process capability, and Gage R&Rs
- 12 paid holidays annually
- Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
- Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
About the Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers... Read more