Senior Quality Engineer - NPI (Onsite)
Stryker
Senior Quality Engineer - NPI (Onsite)
Job Description
Work Flexibility: OnsiteStryker is hiring a Senior Quality Engineer - New Product Introduction (NPI) to support our Neurovascular division. This is an onsite role based in Salt Lake City, UT.As the Senior Quality Engineer - NPI, you will collaborate across functions to provide quality assurance support for all aspects of New Product Introductions, focusing on long-term strategies for Quality, Risk Management, Inspection & Testing, and Suppliers to ensure product competitiveness and compliance with domestic and international regulations.What You Will DoSupport risk management activities by maintaining Risk Management Files, conducting process FMEAs, implementing risk controls, and evaluating process risks throughout the product lifecycle.Ensure compliance with ISO 14971 requirements and contribute to Critical-to-Quality identification, design risk assessments, and risk management documentation.Develop and execute validation strategies, including Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification (PQ).Support Production Part Approval Process (PPAP), process validation, test method validation, and First Article Inspection activities for new product introduction projects.Implement inspection and validation approaches that support scalable, compliant, and cost-effective manufacturing processes.Apply statistical methods, process capability analysis, and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products.Collaborate with suppliers by supporting qualification strategies, reviewing validation activities, and providing quality input for supplier selection, certification, and quality agreements.Represent Quality Assurance during design transfer activities, monitor launch quality metrics such as right-first-time performance, inspection costs, and product escape rates, and provide post-launch quality support.What You NeedRequiredBachelor’s degree in Engineering, Science, or a related technical fieldMinimum 2 years of full-time work experience in Quality Assurance, Quality Engineering, Design Transfer, Manufacturing Engineering, or related functions within the medical device industryMinimum 2 years of full-time work experience in a regulated industry environmentPreferredMinimum 2 years of experience in an engineering role within the medical device industryASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificationExperience working with ISO 13485 and ISO 14971 standardsExperience with process validation, test method validation, FMEA, statistical analysis, process capability studies, and Measurement System Analysis (MSA)Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives US5: $81,600 - $136,000 USD Annual Travel Percentage: 20%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 contractor’s legal duty to furnish information.
Locations
- Utah, Salt Lake City
Salary
81,600 - 136,000 USD / yearly
Skills Required
- Quality Assuranceintermediate
- regulated industry environmentintermediate
- engineering role within the medical device industryintermediate
- process validationintermediate
Required Qualifications
- Bachelor’s degree in Engineering, Science, or a related technical field (degree in engineering)
- Minimum 2 years of full-time work experience in Quality Assurance, Quality Engineering, Design Transfer, Manufacturing Engineering, or related functions within the medical device industry (experience, 2 years)
- Minimum 2 years of full-time work experience in a regulated industry environment (experience, 2 years)
- Bachelor’s degree in Engineering, Science, or a related technical field (degree in engineering)
- Minimum 2 years of full-time work experience in Quality Assurance, Quality Engineering, Design Transfer, Manufacturing Engineering, or related functions within the medical device industry (experience, 2 years)
- Minimum 2 years of full-time work experience in a regulated industry environment (experience, 2 years)
Preferred Qualifications
- Minimum 2 years of experience in an engineering role within the medical device industry (experience, 2 years)
- ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification (certification)
- Experience working with ISO 13485 and ISO 14971 standards (experience)
- Experience with process validation, test method validation, FMEA, statistical analysis, process capability studies, and Measurement System Analysis (MSA) (experience)
- Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives (experience)
- Minimum 2 years of experience in an engineering role within the medical device industry (experience, 2 years)
- ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification (certification)
- Experience working with ISO 13485 and ISO 14971 standards (experience)
- Experience with process validation, test method validation, FMEA, statistical analysis, process capability studies, and Measurement System Analysis (MSA) (experience)
- Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives (experience)
- US5: $81,600 - $136,000 USD Annual (experience)
Responsibilities
- Support risk management activities by maintaining Risk Management Files, conducting process FMEAs, implementing risk controls, and evaluating process risks throughout the product lifecycle.
- Ensure compliance with ISO 14971 requirements and contribute to Critical-to-Quality identification, design risk assessments, and risk management documentation.
- Develop and execute validation strategies, including Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification (PQ).
- Support Production Part Approval Process (PPAP), process validation, test method validation, and First Article Inspection activities for new product introduction projects.
- Implement inspection and validation approaches that support scalable, compliant, and cost-effective manufacturing processes.
- Apply statistical methods, process capability analysis, and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products.
- Collaborate with suppliers by supporting qualification strategies, reviewing validation activities, and providing quality input for supplier selection, certification, and quality agreements.
- Represent Quality Assurance during design transfer activities, monitor launch quality metrics such as right-first-time performance, inspection costs, and product escape rates, and provide post-launch quality support.
- Support risk management activities by maintaining Risk Management Files, conducting process FMEAs, implementing risk controls, and evaluating process risks throughout the product lifecycle.
- Ensure compliance with ISO 14971 requirements and contribute to Critical-to-Quality identification, design risk assessments, and risk management documentation.
- Develop and execute validation strategies, including Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification (PQ).
- Support Production Part Approval Process (PPAP), process validation, test method validation, and First Article Inspection activities for new product introduction projects.
- Implement inspection and validation approaches that support scalable, compliant, and cost-effective manufacturing processes.
- Apply statistical methods, process capability analysis, and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products.
- Collaborate with suppliers by supporting qualification strategies, reviewing validation activities, and providing quality input for supplier selection, certification, and quality agreements.
- Represent Quality Assurance during design transfer activities, monitor launch quality metrics such as right-first-time performance, inspection costs, and product escape rates, and provide post-launch quality support.
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