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-teamWe 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.comStryker is hiring a Quality Assurance Manager (Hybrid), in Phoenix, Arizona , to support Sustainability Solutions ! In this role, you will lead the quality assurance team at our Tempe and Chandler locations, focusing on quality assurance activities. You will also deliver key quality and compliance results for the site operations.Work Flexibility: Hybrid. This role requires reasonable proximity to our Arizona Stryker facility (s). You should be comfortable working 3-days onsite.Who we want:
Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
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.
Network builders . Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
What you will do:
Leads Quality Assurance team, overseeing product/process performance and continuous improvement of quality assurance programs.
Drives initiatives to meet product performance targets in first pass yields, process DPM, manufacturing loss, and complaint levels.
Partner with SQ teams to reduce supplier DPM and achieve targets.
Supports QA team functions, including risk analysis, production control, NC/CAPA activities, quality system improvements, and audit support (both internal and external.
Ensures control of product/ conformance to customer requirements and relevant regulatory standards.
Manages product/process deviations and implements corrective actions for non-conformances.
Fosters a continuous improvement approach to Quality, ensuring that quality is the responsibility of all site employees.
Ensures quality systems are developed, implemented, and continuously reviewed to ensure compliance with all applicable regulatory requirements.
Responsible for executing internal and external agency site audits/inspections and may serve as Management Representative for the site.
Participates as a member of the Site Leadership Team in the development and implementation of business strategy and objectives.
Develop a pipeline of quality improvement initiatives to enhance product quality, reduce costs, increase efficiency, and improve risk management.
Builds a talented, high-performing QA team through effective training and performance management.
Promotes a positive employee relations environment, fostering open communication, engagement, trust, flexibility, inclusiveness, and teamwork.
What you need:Required:
Bachelor's Degree required. Preferred to be in Engineering, Quality Assurance, or a related discipline.
8+ years' experience in Quality Assurance.
Experience in a regulated industry (Medical, Pharmaceutical, Bio-Medical, Aerospace or Automotive manufacturing environment) is required.
2+ previous people management experience is required.
Preferred:
Proven leadership in developing and implementing organizational and functional strategies, initiating change, and driving QA improvements.
Ability to build trust and develop organizational relationships.
Strong problem-solving and data analysis skills for making informed decisions.
Skilled in timely decision-making and developing effective solutions.
Experienced in mentoring, coaching, and managing team performance.
Experienced in managing FDA and regulatory body inspections/audits.
Knowledgeable in 21 CFR Part 820 and ISO 13485.
Working knowledge in quality tools like SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
Effective in influencing and convincing others through interpersonal skills.
Adept at resolving conflicts and developing mutually satisfying outcomes.
Capable of motivating and enabling others to contribute to organizational effectiveness.
Successful in collaborating, learning from others, and building consensus.
Effective communicator with diverse internal and external audiences.
About StrykerOur 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 StrykerStryker 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.
