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Senior Quality Engineer, New Product Introduction
Stryker
Irvine, USA
Full-time
Senior · 2+ years experience
Onsite
USD 89400-148900 / year
Discovered 1 weeks ago
Full Job Posting
What you will do
- Support new product and process introductions by executing and documenting quality engineering activities throughout design transfer and product launch.
- Apply risk management principles to process risk assessments, risk mitigation, process controls, and Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971.
- Develop inspection strategies, sampling plans, First Article Inspection approaches, and Measurement System Analysis (MSA) strategies to support repeatable and scalable manufacturing processes.
- Support the development, execution, review, and approval of process validation protocols and reports, including sterilization validation activities when applicable.
- Apply statistical methods and quality engineering tools to evaluate process capability, identify risks, investigate nonconformances, and support corrective and preventive actions.
- Support Design for Manufacturing and Assembly through process design, inspection optimization, tooling and fixture development, and production specification development.
- Execute supplier quality activities, including supplier qualification, validation, Production Part Approval Process (PPAP), supplier certification, and Quality Agreements.
- Partner with cross-functional teams during design reviews and design transfer activities, documenting quality deliverables and transferring product and process knowledge to manufacturing and Quality Engineering teams.
- What you will need
- Required
- Bachelor’s degree in Engineering or a related technical discipline.
- Minimum 2 years of experience in quality, engineering or technical discipline
- Experience in a regulated manufacturing environment.
- Experience with risk management and process controls.
- Preferred
- Experience in new product or new process introduction.
- Certified Quality Engineer (CQE) certification or equivalent quality engineering coursework or experience.
- Experience with medical device manufacturing and quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
- Lean Six Sigma training and experience with quality and statistical tools such as PFMEA, MSA, process capability, statistical sampling, and DMAIC.
- Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.
- $89,400 - $148,900 USD Annual
Qualifications
- Bachelor’s degree in Engineering or a related technical discipline.
- Experience with risk management and process controls.
- Experience with medical device manufacturing and quality requirements, including ISO 13485, Good Manufacturing Practices, and Good Documentation Practices.
- Experience with supplier qualification and supplier quality activities supporting new product introduction and manufacturing.
About Stryker
Healthcare10,001+Founded 1941
Stryker is a global medical technology company offering innovative products and services in surgical equipment, neurotechnology, orthopaedics, and spine care.
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