Senior Manager, Sterility Assurance (Remote)

Why RA/QA 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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

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

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

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based 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.

Stryker is hiring a SENIOR MANAGER, STERILITY ASSURANCE (Remote)! The Senior Manager will lead a Global team in support of cleaning, disinfection, and moist heat sterilization of reusable medical devices as well as terminal sterilization of medical devices using Ethylene Oxide & Radiation modalities (Gamma & E-beam). They will closely partner with R&D teams to develop new products and lead continuous quality improvement initiatives and actively participate in projects that develop and improve processes relating to the Device Reprocessing and Terminal Sterilization program.

Workplace Flexibility: This role allows majority of work from an alternate USA location but will have travel expectations to other Stryker facilities on an as needed basis.

Who we want-

• Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
• Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you will do-

• All other duties as assigned.
• Establish robust programs relating to device reprocessing; cleaning, thermal disinfection moist heat sterilization & terminal sterilization modalities. Lead and participate in the development and improvement of processes for existing and new products with minimal support- Device reprocessing & Terminal sterilization strategies
• Establish standard process to ensure appropriate resolution and management of the responsible task owner.
• Communicate and collaborate with Quality, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
• Support the development, review and approval of sterilization process for equipment validation/qualifications (IQ, OQ & PQ) and products.
• Independently conduct audits of sterilization processes.
• Manage day-to-day processes to ensure issues are appropriately evaluated. Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.
• Recruit, select, and on-board top talent.
• Develop talent within team to increase performance. Actively address performance issues on team.
• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
• Provide input to Labelling requirements relating to reusables.
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
• Identify & support qualification of new device reprocessing technologies & terminal sterilization modalities
• Maintain a high level of team engagement.
• Analysis of Data & Trouble shooting
• Interpret & Apply ISO, FDA and Country specific guidelines to the biological analysis of medical instrumentation and surgical products.
• Support and advise regulatory teams on the review and writing of 510(k) & Notified Body submissions.
• Define suitable risk strategy to address nonconforming material and system documentation.
• Manage and provide updates for quality metrics. Implement appropriate enhancements.
• Develop training for new microbiology team members and external departments.
• Liaise with test house facilities in relation to design and execution of validation studies.
• Utilize experience with medical device product development lifecycle, including risk management and design/process verification and validation!
• Serve as Subject Matter Expert for Device Reprocessing & Terminal sterilization programs.
• Represent sterility during internal and external audits.
• Chair meetings required to drive closure of quality issues.

What you need-

Required

• Bachelor’s Degree in Microbiology, Biology or science related field.
• Must have prior experience managing a team
• Minimum 10 years’ experience in medical device or regulated industry

Preferred

• Experience with biological testing, research and development, or sterility assurance experience.
• Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures.
• Masters degree preferred.

122,800.00 to 271,400.00 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com