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

• 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.

• Lead new product development and/or changes to medical devices currently on the market for biocompatibility/toxicology.
• Lead biocompatibility toxicological assessments, evaluate test data, and present results to cross-functional team.
• Lead departmental initiatives including setting timelines and milestones.
• Write and present technical and scientific documentation.
• Maintain communications with internal customers.
• Partner with cross functional teams including (RA, AO, Ops) to ensure business unit project timelines are met.
• Partner with team by contributing to the development, maintenance, and improvements of 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, and out-of-specification investigations.
• Define validation activities (i.e. product adoptions, testing plans, etc.).
• Train junior scientists and other functions in area of biocompatibility.

• BS in Chemistry/Biochemistry/Toxicology or related discipline

• 4+ years related experience in medical device, pharmaceutical or chemical industry.

• MS in Chemistry/Biochemistry/Toxicology or related discipline
• 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 and desire to work effectively in a fast-paced multi-disciplinary team environment.
• Strong interpersonal skills including strong written and oral communication.
• 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.
• Demonstrated ability to work independently.

• 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.