Manager, Quality Assurance New Product Introduction (Hybrid)
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Job Location:
Salt Lake, UT - USA
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a Manager Quality Assurance - New Product Introduction for our Neurovascular division. This is a hybrid position based two to three days per week in our Salt Lake City UT office.
As the Manager Quality Assurance NPI you will serve as a global leader and strategic partner within the NPI Quality organization. This role champions design for manufacturability and assembly providing technical leadership to ensure new products processes and technologies are introduced with robust process risk management and highquality outcomes. You will guide the team in driving preventative quality strengthening process capability and enabling successful compliant product launches.
What You Will Do
Lead the execution of NPI quality strategy to develop capable scalable manufacturing processes and highyield product launches.
Drive robust pFMEA CQA identification process validation process capability and supplier capability to ensure accurate risk identification and strong process controls.
Oversee implementation of production and process controls inspection strategies and test method validations to support high-quality lowcost product introductions.
Partner crossfunctionally with Design Advanced Operations GQO and suppliers to strengthen collaboration share best practices and harmonize global NPI QA processes.
Coach develop and empower NPI QA team members ensuring strong technical capability metrology expertise and performance management practices.
Build organizational capability through optimized lean inspection approaches automation opportunities supplier certification and technologyenabled improvements.
Monitor and influence quality performance indicators (supplier DPM RFT manufacturing loss complaints recalls) and identify opportunities for continuous improvement.
Ensure adherence to corporate GQO and external regulatory requirements (including FDA and global standards) supporting high-quality design transfers and compliant product launches.
What You Need
Required
Bachelors Degree in Engineering Science discipline or equivalent
Minimum of 8 years experience in medical device pharmaceutical biomedical aerospace automotive or other regulated manufacturing environments
Minimum of 2 years experience and a proven track record of successfully building managing and developing a highly talented engaged and performing team
Expert working knowledge of regulatory requirements standards and regulations with experience of managing inspections/audits by the FDA and other regulatory bodies
Proven ability to build trust navigate crossfunctional relationships and advocate for quality in a technical environment
Preferred
MBA or background in Business Management
Proficiency in quality tools such as SPC FMEA RCA PokaYoke and Six Sigma methodologies
Experience across multiple quality roles sites or functions
Expertise in metrology GD&T and interpretation of complex engineering drawings
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
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
