Quality Management System Specialist

Portage, WI - USA

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

Quality Management System Specialist

Portage - MI

In this role you will help design maintain and continuously improve a quality management system that supports regulatory approval and business growth across global markets. Youll collaborate across functions to ensure quality processes are not only compliant but practical efficient and futureready.

Work Flexibility

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

What You Will Do

Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances.
Develop and update quality system processes procedures and documentation to reflect business needs and regulatory expectations.
Assess and quantify quality system requirements to optimize structure integration and scalability.
Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes.
Support management review quality planning forums and related governance activities with data-driven inputs.
Partner with stakeholders to ensure quality processes reflect actual operational activities including support for new product development.
Prepare for and support internal external and thirdparty quality system audits including responses and followup actions.
Contribute to quality system training content and delivery to ensure effective adoption across the organization.

What You Will Need

Required

Bachelors degree in science engineering business or a related discipline.
0 years of experience working in a regulated industry environment.

Preferred

Knowledge of U.S. and international medical device regulatory requirements.
Experience supporting quality systems such as audits management review quality planning and corrective action processes.
Experience supporting regulated information systems or quality systems change control.
Exposure to good manufacturing and distribution practices within a quality environment.

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:

Work Flexibility: HybridQuality Management System SpecialistPortage - MIIn this role you will help design maintain and continuously improve a quality management system that supports regulatory approval and business growth across global markets. Youll collaborate across functions to ensure quality pr...

Work Flexibility: Hybrid

Quality Management System Specialist

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

Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances.
Develop and update quality system processes procedures and documentation to reflect business needs and regulatory expectations.
Assess and quantify quality system requirements to optimize structure integration and scalability.
Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes.
Support management review quality planning forums and related governance activities with data-driven inputs.
Partner with stakeholders to ensure quality processes reflect actual operational activities including support for new product development.
Prepare for and support internal external and thirdparty quality system audits including responses and followup actions.
Contribute to quality system training content and delivery to ensure effective adoption across the organization.

What You Will Need

Required

Bachelors degree in science engineering business or a related discipline.
0 years of experience working in a regulated industry environment.

Preferred

Knowledge of U.S. and international medical device regulatory requirements.
Experience supporting quality systems such as audits management review quality planning and corrective action processes.
Experience supporting regulated information systems or quality systems change control.
Exposure to good manufacturing and distribution practices within a quality environment.

Travel Percentage: 10%

Required Experience:

Key Skills

Computer Science
Active Directory
Clearance
Facility
HVAC
Linux
Project Management
Troubleshoot
Desktop
Control Systems
Management System
Setup
hardware
Data Analysis
Technical Support

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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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