Staff Quality Engineer, NPI
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Job Location:
San Jose, CA - USA
Monthly Salary:
$ 113900 - 186700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
As a Staff NPI Quality Engineer you will provide quality assurance support for all aspects of New Product Introductions (NPI) ensuring compliance with domestic and international regulations while driving product competitiveness. This role focuses on Design Control Process Validation Supplier Quality Risk Management and NC/CAPA throughout the product lifecycle.
What You Will Do
- Drive quality strategies for inspection testing and supplier qualification during new product development.
- Ensure proper linkage between design inputs/outputs process controls and customer needs during design transfer.
- Develop inspection documents validate test methods and implement inspection strategies for NPI projects.
- Lead or support process validation activities (IQ/OQ/PQ) including protocol development and execution.
- Identify audit and onboard new suppliers lead component and product qualification activities.
- Create and maintain process risk documentation per ISO 14971 for regulatory submissions.
- Investigate and close non-conformances and CAPAs related to new product development.
- Support creation of Device Master Records and training during production process transfer.
- Collaborate with cross-functional teams to ensure compliance with ISO 13485 FDA regulations and internal quality systems.
- Promote a customer-centric quality culture and support internal/external audits.
What You Need
- Bachelors degree in engineering or related field.
- 5 years of experience in Quality Engineering within medical device or regulated industry.
- Strong knowledge of Design Control Process Validation Risk Management and Supplier Quality.
- Familiarity with ISO 13485 ISO 14971 and FDA regulations.
- Excellent communication and leadership skills; ability to train and influence cross-functional teams.
Preferred
- Masters degree in relevant field desired.
- ASQ-CQE CQA or equivalent course work/experience desired.
- Experience with electrical/electro-mechanical systems electrical V&V (IEC 60601 EMC/EMI) automated test equipment (LabVIEW/TestStand) electrical DFMEA/PFMEA PCBA supplier qualification and relevant certifications.
- Experience with statistical rationale for validation sterilization validation strategies and post-launch monitoring.
- Advanced understanding of inspection strategies and test method validation
- $113900.00 - 186700.00 USD Annual salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Posted: December 09 2025
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:
Staff IC
Key Skills
- Computer Science
- Docker
- Kubernetes
- Python
- VMware
- C/C++
- Go
- System Architecture
- gRPC
- OS Kernels
- Perl
- Distributed Systems
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
