Staff Quality Engineer, OEMCM

Portage, WI - USA

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

Staff Quality Engineer OEM/CM

Portage MI

Join a team that ensures patients receive safe reliable highquality products through excellence in supplier this role you will strengthen Strykers external supply chain by driving supplier performance improving manufacturing capability and supporting continuous improvement across OEM/CM partners. This is an exciting opportunity to influence product quality at scale and partner across global teams to deliver meaningful impact.

Work Flexibility:

Hybrid - must reside within a commutable distance to Portage MI and work onsite several times per week.

What You Will Do

Lead quality issue resolution with OEM/CM partners ensuring timely containment corrective actions and clear communication to internal stakeholders.
Evaluate supplier performance through KPIs data analysis and monthly reviews to ensure ongoing compliance with quality service and cost expectations.
Participate in external and internal audits supporting regulatory compliance with GMP and global medical device requirements.
Maintain accuracy and integrity of supplier quality data including Approved Supplier List updates and OEM/CM documentation.
Collaborate with sourcing manufacturing and quality teams to assess and address material quality issues and supplier changes.
Support Material Review Board processes ensuring efficient assessment and disposition of nonconforming materials.
Drive continuous improvement initiatives with OEM/CMs to enhance process capability reduce defects and strengthen supply chain performance.
Contribute to supplier audit planning execution and closure ensuring alignment with regulatory and corporate quality system expectations.

What You Will Need

Required Qualifications

Bachelors degree in Engineering or Science field or equivalent technical discipline.
4 years of experience in a manufacturing environment or equivalent.
Knowledge of GMP ISO 13485 and 21 CFR Part 820 standards.
Knowledge of FMEA validation programs and statistical process control within a regulated environment.

Preferred Qualifications

Internal Quality Auditor qualification (AS9100 ISO 13485 CFR 820 or comparable standards).
Training or experience with continuous improvement methodologies.

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

Work Flexibility: HybridStaff Quality Engineer OEM/CMPortage MIJoin a team that ensures patients receive safe reliable highquality products through excellence in supplier this role you will strengthen Strykers external supply chain by driving supplier performance improving manufacturing capability ...

Work Flexibility: Hybrid

Staff Quality Engineer OEM/CM

Portage MI

Work Flexibility:

Hybrid - must reside within a commutable distance to Portage MI and work onsite several times per week.

What You Will Do

Lead quality issue resolution with OEM/CM partners ensuring timely containment corrective actions and clear communication to internal stakeholders.
Evaluate supplier performance through KPIs data analysis and monthly reviews to ensure ongoing compliance with quality service and cost expectations.
Participate in external and internal audits supporting regulatory compliance with GMP and global medical device requirements.
Maintain accuracy and integrity of supplier quality data including Approved Supplier List updates and OEM/CM documentation.
Collaborate with sourcing manufacturing and quality teams to assess and address material quality issues and supplier changes.
Support Material Review Board processes ensuring efficient assessment and disposition of nonconforming materials.
Drive continuous improvement initiatives with OEM/CMs to enhance process capability reduce defects and strengthen supply chain performance.
Contribute to supplier audit planning execution and closure ensuring alignment with regulatory and corporate quality system expectations.

What You Will Need

Required Qualifications

Bachelors degree in Engineering or Science field or equivalent technical discipline.
4 years of experience in a manufacturing environment or equivalent.
Knowledge of GMP ISO 13485 and 21 CFR Part 820 standards.
Knowledge of FMEA validation programs and statistical process control within a regulated environment.

Preferred Qualifications

Internal Quality Auditor qualification (AS9100 ISO 13485 CFR 820 or comparable standards).
Training or experience with continuous improvement methodologies.

Travel Percentage: 10%

Required Experience:

Staff IC

Key Skills

Computer Science
Docker
Kubernetes
Python
VMware
C/C++
Go
System Architecture
gRPC
OS Kernels
Perl
Distributed Systems

Apply Now

About Company

Stryker

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

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