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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

Senior Staff Biocompatibility Specialist - Hybrid

Mahwah, NJ

Stryker is hiring a Senior Staff Biocompatibility Specialist to support our Joint Replacement division.

In this role, you will Lead new product development and/or changes to medical devices currently on the market for biocompatibility/toxicology.

Work Flexibility: Hybrid.

This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days onsite.

Who we want:

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Self-directed initiators. People who take ownership of their work, results-oriented, and need no prompting to drive productivity, change, and outcomes.

• Team-players. People who can collaborate globally and thrive when developing lasting interpersonal relationships.

What you will do:

• Lead biocompatibility toxicological assessments, evaluate test data, and present results to cross-functional team.

• Lead complex departmental initiatives, which may require cross functional collaboration, including setting timelines and milestones.

• Write and present technical and scientific documentation .

• Evaluate the optimization and implement improvements in the policies and procedures related to biocompatibility.

• Act as biocompatibility subject matter expert to align to best practices, benchmarking against industry leads and regulatory requirements.

• Lead root cause analysis, problem solving, out-of-specification investigations, as well as associated risk assessments.

• Evaluate validation and verification approaches for biocompatibility (i.e. product adoptions, testing plans, etc.).

What you need:

Required:

• BS in Chemistry/Biochemistry/Toxicology or related discipline

• 6+ years of experience in medical device, pharmaceutical or chemical industry

Preferred:

• MS in Chemistry/Biochemistry/Toxicology or PhD in Chemistry/Biochemistry/Toxicology or related discipline

• Expert knowledge of GDP, ANSI, AAMI, ISO, FDA, and USP guidelines related to biocompatibility assessments (i.e. ISO 10993, ISO 22442, etc).

• Demonstrated ability to effectively communicate, manage projects, and influence as well as can prioritize and manage multiple tasks simultaneously.

• Ability to work effectively in a fast-paced multi-disciplinary team environment.

• Strong in critical and analytical thinking.

• Highly developed problem-solving skills.

• Demonstrated ability to write technical documentation.

• Demonstrated ability to successfully manage and complete projects in a matrix organization.

About Stryker

Our benefits:

• 12 paid holidays annually

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)

About 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. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)

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 on our referral page (https://careers.stryker.com/referrals/)

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

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.