Associate Supervisor IQA/MQA

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Essential Duties & Responsibilities:

• Provide immediate supervision and support to a group of technical employees across multiple shifts. Supervision of employees constitutes the primary role of the position.
• Lead QC CI initiatives in alignment with regional and plant strategies.
• Support Quality Projects that involve the IQA and MQA department.
• Driving team to compliance with productivity and efficiency metrics.
• Support activities related to CAPA and NC within the area, including ownership of records.
• Administer the LX/QMS electronic document management system for the incoming inspection process and batch release process.
• Perform assessment(s) of incoming inspection process and batch release process and propose improvements to current policies and practices and implement as directed.
• Trouble shoot issues related to the review and release of product.
• Coordinate daily scheduling and planning of product sampling, inspection and release.
• Provide opportunities for employee development.
• Maintain various spreadsheets and databases (requires heavy use of Excel, Word, MS Outlook and similar database programs).
• Communicate with Warehouse and Manufacturing personnel regarding the release and movement of materials/components.
• Communicate with various departments regarding the release status of materials, identified nonconformities or disruptions in the inspection process.
• Conduct revisions to procedures and forms as well as document approvals.
• Perform documentation activities that adhere to cGMP and GDP.
• Support audit activities as subject matter expert for area.
• Perform inspection activities for various raw materials, components & finished goods conformance to the specification or drawing.
• Sample and test received raw materials, components & finished goods that require inspection and release prior to use in manufacturing.
• Use of aseptic techniques to sample chemicals and raw materials.
• Use of various measurement tools and instruments: calipers, scales, thickness gauges, force gauges, optical comparator, Raman spectrophotometer, pipets, and other systems.
• Perform inspection activities of printed materials against master documents for differences.
• Perform other duties as assigned.

Education & Special Trainings

• Bachelor’s degree required.
• At least 3 years equivalent job experience.

Qualifications & Experience:

• General knowledge of FDA regulations for drugs and medical devices.
• Previous experience in a leadership role and demonstration of leadership skills required.
• Exceptional organizational and communication skills.
• Ability to perform review of documentation with a high level of attention to detail.
• Ability to take direction, work independently and be adaptable in an ever-changing environment.
• Capability to handle heavy computer use and work in multiple systems.
• Proficiency with Microsoft Office (Word, Excel, etc.) required.
• Aptitude to multi-task and prioritize work.
• Possesses a high level of personal integrity and self-control.
• Physical capability to lift 60 pounds and be mobile throughout a large plant.
• Accepts direction and constructive criticism.

Physical Requirements

• Subject to controlled indoor conditions with some temperature change from occasional task in the warehouse. May be subject to short-term exposure to some hazardous chemicals and reagents.
• Physical activities include: Standing, walking, sitting, lifting up to 60lbs, carrying, reaching, handling, talking, hearing, pulling, pushing, keying, grasping.
• Visual activities include: Must be capable of accurately discerning instrument/equipment displays. Good color discrimination.

Mental Requirements

• Long periods of concentration including sample inspection, testing and review of documents. Participation in discussions and planning.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com