Manager, Quality Assurance

Salt Lake, UT - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

Stryker is hiring aManager Quality AssurancesupportingGlobal Quality Business Operations. This is an onsite role based in Salt Lake City UT.

As Manager Quality Assurance you will lead a high-performing team dedicated to ensuring our products meet the highest standards of safety compliance and performance. This is a strategic leadership role where your impact will be felt across operations regulatory audits and global quality initiativesall in support of life-saving neurovascular technologies.

What You Will Do

Lead a team of quality professionals providing technical guidance and fostering a culture of continuous improvement and collaboration.
Ensure site-wide compliance with regulatory standards including ISO 13485 MDR and FDA QSR and maintain certification with all relevant bodies.
Manage internal and external audits acting as deputy Management Representative in the absence of the site head of Quality.
Drive resolution of product and process deviations including supplier-related issues and oversee implementation of effective corrective actions.
Develop and execute a pipeline of quality improvement initiatives focused on product quality risk management and operational efficiency.
Monitor Quality KPIs and business metrics taking timely action to address adverse trends and support strategic planning.
Collaborate globally by leading cross-functional and cross-site process improvement initiatives and benchmarking best-in-class practices.
Support talent development through effective training performance management and succession planning for the quality team.

What You Need

Bachelors degree in engineering quality assurance or related scientific discipline
Minimum 8 years of experience in an FDA regulated industry (medical device pharmaceutical etc.)
Minimum 2 years of management experience

Preferred

Experience with quality tools methodologies and project management systems (e.g. Microsoft Project)
Demonstrated auditing experience in medical device or regulated manufacturing environments
Applied understanding of 21 CFR 820 ISO 13485 MDR and other applicable regulations
Experience developing quality management systems training programs and lean documentation
Certification or coursework in Six Sigma ASQ-CQE or CQA

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:

Manager

Work Flexibility: OnsiteStryker is hiring aManager Quality AssurancesupportingGlobal Quality Business Operations. This is an onsite role based in Salt Lake City UT.As Manager Quality Assurance you will lead a high-performing team dedicated to ensuring our products meet the highest standards of safet...

Work Flexibility: Onsite

Stryker is hiring aManager Quality AssurancesupportingGlobal Quality Business Operations. This is an onsite role based in Salt Lake City UT.

What You Will Do

Lead a team of quality professionals providing technical guidance and fostering a culture of continuous improvement and collaboration.
Ensure site-wide compliance with regulatory standards including ISO 13485 MDR and FDA QSR and maintain certification with all relevant bodies.
Manage internal and external audits acting as deputy Management Representative in the absence of the site head of Quality.
Drive resolution of product and process deviations including supplier-related issues and oversee implementation of effective corrective actions.
Develop and execute a pipeline of quality improvement initiatives focused on product quality risk management and operational efficiency.
Monitor Quality KPIs and business metrics taking timely action to address adverse trends and support strategic planning.
Collaborate globally by leading cross-functional and cross-site process improvement initiatives and benchmarking best-in-class practices.
Support talent development through effective training performance management and succession planning for the quality team.

What You Need

Bachelors degree in engineering quality assurance or related scientific discipline
Minimum 8 years of experience in an FDA regulated industry (medical device pharmaceutical etc.)
Minimum 2 years of management experience

Preferred

Experience with quality tools methodologies and project management systems (e.g. Microsoft Project)
Demonstrated auditing experience in medical device or regulated manufacturing environments
Applied understanding of 21 CFR 820 ISO 13485 MDR and other applicable regulations
Experience developing quality management systems training programs and lean documentation
Certification or coursework in Six Sigma ASQ-CQE or CQA

Travel Percentage: 10%

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

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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