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 a Manager, Quality Assurance in Salt Lake City, Utah, supporting Neurovascular! In this role, you will be responsible to lead and manage a group of Quality professionals to ensure a high level of Quality Management System and regulatory compliance in the plant. This position will be responsible for Quality Management System implementation, supporting Management Review, coordinating third party audits (FDA, ISO, etc.) and management of the operations quality engineering function. Serves as deputy Management Representative in the absence of the site head of Quality.

　　 Who we want:

　　Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing the right activities that lead to success. Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

　　What you will do:

　　Leadership of a high performing quality team, that provides direct support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality.Ensure that the organization's conformance and commitment to producing products meets or exceeds 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.Champions 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 Quality functions (e.g. Shared Services Quality, Supplier Quality) are included in decision making processes as part of continuous improvement, problem solving and projects.Selects competent talent and supports the development of their future potential. Ensures effective training and performance management of the teams.Ensures 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. Manages product & patient risk.Develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NC & 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.Foster strong collaboration on a global scale by participating in and leading cross functional and global process improvement initiatives.Has a strategic view in identifying global alignment and developing strategies for best-in-class practices and benchmark against industry leads and regulatory requirements for the Quality function.

　　Required:

　　Bachelor's degree required. Engineering, Quality Assurance, or related scientific discipline preferred.8+ years' experience in the medical device, pharmaceutical, and/or regulated industry.2+ years of management experience.

　　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 21 CFR 820, MDD, MDR, ISO 13485 and applicable regulations.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 leadership ability and experience.Demonstrated PC proficiency. Demonstrated organizational and written/verbal communication skills.Demonstrated ability to self-motivateDemonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.Demonstrated ability to prioritize tasks in a deadline-driven environment.

　　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

　　About Stryker

　　Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, 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.

　　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

　　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.