Engineer, Service Quality
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Job Location:
San Jose, CA - USA
Monthly Salary:
$ 90400 - 144200
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Stryker is hiring an Engineer Service Quality in San Jose CA! In this role youll support service processes ensuring quality standards for repaired refurbished and returned medical devices. Youll drive cost improvements reduce regulatory risk and support lean manufacturing initiatives to keep our Service Depot running efficiently.
Key responsibilities include troubleshooting and advising service teams investigating product issues documenting defects analyzing trends and leading process improvements across multiple product lines.
What You Will Do
Maintain compliance and quality standards for repair and refurbishment processes.
Lead implementation of process improvements to enhance efficiency and reduce regulatory risk.
Drive continuous improvement initiatives to reduce lead time cost and quality issues.
Monitor and analyze key quality metrics taking proactive corrective actions.
Own and manage nonconformances (NCs) and corrective/preventive actions (CAPAs) for assigned products.
Troubleshoot moderately complex product quality issues using data-driven analysis.
Ensure accurate documentation for inspection testing and repair procedures and train technicians on updates.
Partner with technicians and supervisors to optimize processes and meet demand requirements.
Process supplier requests and maintain supporting documentation.
Provide input and support implementation of repair and testing mechanisms and equipment.
Validate equipment and third-party repaired components to ensure compliance.
Contribute to new product development by recommending efficient repair techniques based on current data.
Support internal and external audits including FDA and Notified Body inspections.
What You Will Need
Required Qualifications
Bachelors degree in engineering science or related.
0 years of experience in engineering manufacturing quality or a highly regulated industry.
Preferred Qualifications
Internship experience in quality engineering or manufacturing is strongly preferred
Knowledge of FDA QSR ISO13485 ISO9001 and related quality system standards
Experience managing NCs and CAPAs
Lean Six Sigma and root cause analysis methodologies
$90400 - $144200 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
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:
IC
Key Skills
- Debugging
- Computer Networking
- ConnectWise
- PKI
- PowerShell
- Windows
- C#
- Automotive Diagnostics
- Medical Imaging
- Azure
- Technical Support
- Troubleshooting
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
