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 Neurovascular is hiring an Associate Quality Manager in Salt Lake City, Utah ! As leader of a dedicated Quality Operations team within the Salt Lake City Operations Quality team, provide direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Has responsibility for delivering the compliance and business objectives of the function, with primary responsibility to drive engagement and lead the quality team while ensuring compliance to Stryker Corporate and local requirements, Quality System Regulations, and applicable medical device standards.

　　Who we want

　　Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

　　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.

　　What you will do

　　Leads a subset of the Quality Engineering team, to provide support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality.

　　Supports and algins with the site commitment to ensure the organization’s conformance to producing products meeting or exceeding customer requirements and the relevant regulatory standards.

　　Drive an environment of compliance within Stryker by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these standards.

　　Fosters a positive employee environment by promoting open communication, engagement and development of team members. Promotes a culture of trust, flexibility, teamwork and inclusiveness, ensuring all relevant functions are included in decision making processes as part of continuous improvement, problem solving and projects.

　　Creates a highly talented team by recruiting, hiring, and developing individuals in positions aligned with their future potential. Ensures effective training and performance management of the teams.

　　Participate in ensuring the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programs such as Corporate, notified body & FDA audits.

　　Ensures effective management and control of product/process deviations including those of suppliers for all released product and for the implementation of effective corrective action when non-conformances arise. Assesses product & patient risk.

　　Supports development of a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management.

　　Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement.

　　Assist in developing and supporting local and global strategies for the Operations Quality function.

　　What you need

　　Required:

　　BS degree in Engineering, Science discipline, or equivalent field

　　6+ years’ experience in Quality related field within medical device or other regulated manufacturing environment (biotech, pharma, military/space, etc.).

　　Preferred :

　　Master's Degree or equivalent additional coursework, preferred

　　Certification as ASQ Certified Quality Engineer and/or Certified Manager of Quality /Operational Excellence preferred

　　Demonstrated use of Quality tools/methodologies and project management skills.

　　Experience managing a team. Management of professional level quality staff preferred.

　　Demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as Microsoft Project.

　　Demonstrated experience in developing quality management systems; design and development of training programs/courses; lean documentation; and Six Sigma methodology.

　　Demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military/space).

　　Applied understanding of CGMPs, ISO 9001, ISO 13485, and CMDR.

　　Demonstrated ability to effectively advocate a strategic quality systems approach and lead the organization to compliance.

　　Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.

　　Demonstrated organizational and written/verbal communication skills.

　　Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams

　　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.