Supervisor, Quality Control

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

Stryker Inari is hiring a Quality Control Supervisor in Irvine CA to provide technical supervision to oversee/support the quality department with incoming in-process and finished product inspections including product validation testing.

Workplace Flexibility: 2nd Shift (Onsite Role):
This position operates on the 2nd shift schedule from 2:00 PM to 10:30 PM overseeing a team whose working hours are 3:30 PM to 12:00 AM. The supervisor begins earlier to ensure a smooth and effective transition between the 1st and 2nd shifts. This is a 100% onsite role requiring hands-on leadership and coordination.

What you will do

Lead and supervise QC personnel in developing implementing and maintaining the Quality Management System in compliance with FDA Quality System Regulation ISO 13485 and other applicable standards.
Oversee daily QC operations including Receiving Inspection In-Process Inspection and Final Inspections across assigned business units to ensure quality objectives are met.
Execute quality-related processes throughout the product lifecyclefrom development and launch to manufacturing distribution and post-market follow-upwhile developing global processes and implementing them locally.
Participate in global development and product improvement projects to ensure quality aspects are addressed and integrated effectively.
Collaborate with Manufacturing and Engineering teams to provide quality feedback and training to production staff ensuring alignment and continuous improvement.
Support company-wide QSR and ISO training initiatives and monitor product/process requirements including initiating and analyzing non-conformances.
Review and act on nonconformances related to incoming in-process and finished products; ensure timely raw material inspections and confirm materials meet specifications and drawings.
Ensure QC personnel are properly trained coordinate daily activities across all QC shifts to support manufacturing and engineering goals and perform other duties as assigned.

What you need

Required

Bachelors degree or an equivalent of 6 years of professional experience with a minimum of 2 years of QA/QC experience with a strong commitment to adhering to internal procedures and compliance standards.
Ability to read and interpret blueprints to ensure accurate understanding of technical specifications support quality inspections and verify product compliance with design requirements.
Proficient in Microsoft Office (especially Word and Excel) with strong computer and math skills for calibration and measurement; comfortable with extensive computer usage.
Ability to lift up to 30 lbs. occasionally and tolerate extended periods of sitting standing walking and speaking.

Preferred

Demonstrated leadership experience with the ability to guide teams support quality initiatives and foster a collaborative work environment.
Experience in the medical device industry with familiarity in regulatory requirements quality standards and industry-specific best practices.

69100.00 to 139600.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage: 0%

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 Inari is hiring a Quality Control Supervisor in Irvine CA to provide technical supervision to oversee/support the quality department with incoming in-process and finished product inspections including product validation testing.Workplace Flexibility: 2nd Shift (Onsit...

Work Flexibility: Onsite

What you will do

Lead and supervise QC personnel in developing implementing and maintaining the Quality Management System in compliance with FDA Quality System Regulation ISO 13485 and other applicable standards.
Oversee daily QC operations including Receiving Inspection In-Process Inspection and Final Inspections across assigned business units to ensure quality objectives are met.
Execute quality-related processes throughout the product lifecyclefrom development and launch to manufacturing distribution and post-market follow-upwhile developing global processes and implementing them locally.
Participate in global development and product improvement projects to ensure quality aspects are addressed and integrated effectively.
Collaborate with Manufacturing and Engineering teams to provide quality feedback and training to production staff ensuring alignment and continuous improvement.
Support company-wide QSR and ISO training initiatives and monitor product/process requirements including initiating and analyzing non-conformances.
Review and act on nonconformances related to incoming in-process and finished products; ensure timely raw material inspections and confirm materials meet specifications and drawings.
Ensure QC personnel are properly trained coordinate daily activities across all QC shifts to support manufacturing and engineering goals and perform other duties as assigned.

What you need

Required

Bachelors degree or an equivalent of 6 years of professional experience with a minimum of 2 years of QA/QC experience with a strong commitment to adhering to internal procedures and compliance standards.
Ability to read and interpret blueprints to ensure accurate understanding of technical specifications support quality inspections and verify product compliance with design requirements.
Proficient in Microsoft Office (especially Word and Excel) with strong computer and math skills for calibration and measurement; comfortable with extensive computer usage.
Ability to lift up to 30 lbs. occasionally and tolerate extended periods of sitting standing walking and speaking.

Preferred

Demonstrated leadership experience with the ability to guide teams support quality initiatives and foster a collaborative work environment.
Experience in the medical device industry with familiarity in regulatory requirements quality standards and industry-specific best practices.

69100.00 to 139600.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage: 0%

Required Experience:

Manager

Key Skills

Laboratory Experience
Quality Assurance
FDA Regulations
ISO 9001
Quality Systems
Microbiology
Quality Control
cGMP
Laboratory Information Management Systems
QA/QC
HACCP
Manufacturing

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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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