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

Stryker is hiring an Associate Quality Manager, New Product Introduction (Hybrid or Onsite) in Salt Lake City, Utah, to support Neurovascular! As a leader of NPI Quality Assurance (QA) engineers, you will advocate and lead design for manufacture and assembly through technical leadership and direction in quality assurance for new product launches. You will influence the development and introduction of new products, processes, and technologies, with focus on process risk management including robust pFMEA to deliver highest quality products at launch. Additionally, you will inspire the NPI team to drive preventative measures and improvement of product and process design.

Work Flexibility: Hybrid or Onsite. This role requires reasonable proximity to our Stryker facility. You should be comfortable working a few days a week onsite.

Who we want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• 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:

Working within the NPI Quality structure, in a management capacity, has responsibility for quality related activities, including, but not limited to the following:

• Sets direction: Drives the execution of new product development strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.

• Builds organizational capability: Promotes the optimization of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit.

• Inspires others : Coaching and development of staff who champion quality assurance during the product development process, ensuring product launches meet or exceed established metrics.

• Delivers results: Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.

• Drives robust pFMEA and critical to quality attributes (CQA) identification to deliver accurate process risk identification, process characterization, process validation, process capability, robust process control and supplier capability.

• Fosters collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with new product launch.

• Collaborates with NPI QA teams/leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the NPI QA team.

• Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful New Product Introductions that meet the NPI project goals as well as the regulatory requirements.

• Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets per the design transfer agreement plan (DTAP). Continuously monitors to assess opportunities for improvement.

• Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed.

• Advocates for the design of robust inspection strategies including CQA's, CTQ's and test method validations.

• Guides the team to onboard suppliers with demonstrated quality, process capability and validation. Ensures robust supplier pFMEA, PPAP, supplier certification and inspection methods where appropriate.

• Influences processes towards validation versus manual verification, where possible.

• Drives competency in metrology within the quality assurance NPI team including interpretation of complex engineering drawings and understanding of geometrical dimensioning and tolerance.

• Ensures compliance to Stryker Corporate, GQO and external regulatory requirements.

What you need:

Required:

• Bachelor's Degree in Engineering, Science discipline or equivalent required.

• 6+ years of experience in a Medical, Pharmaceutical, Bio-Medical/Pharma or regulated manufacturing environment.

Preferred:

• Experience of successfully creating and managing a talented, engaged and performing team is advantageous.

• Ability to implement organization and functional strategy.

• Ability to initiate and implement change with a demonstrated track record (at individual level or team level)

• Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other bodies.

• Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.

• Initiates, sponsors, and implements change with a demonstrated track record.

• Ability to effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.

• Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions.

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.