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

　　Associate Manager, Quality Assurance NPI (Hybrid)

　　Stryker is hiring an Associate Manager, Quality Assurance New Product Introduction in Mahwah, NJ. As a leader of NPI Quality Assurance, this role, advocates and leads design for manufacture and assembly, robust production & process control development, through technical leadership and direction in quality assurance for new product launches, with a focus on external products and processes. This leader will influence the development and introduction of new products, processes, and technologies, with focus on external supplier process risk management including robust pFMEA, and robust production & process controls development, to deliver highest quality products at launch. This leader will support new products developed for the Joint Replacement Franchise. This is a working manager position who will initially have a percentage of time allocated towards serving as a technical program lead for new products in addition to managing a small team.

　　Work Flexibility: Hybrid.

　　This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days onsite.

　　Who we want

　　Effective communicators . People who regularly share relevant status updates and effectively articulate issues and recommendations to stakeholders and senior management.

　　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

　　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 production and process control 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.

　　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.

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

　　What you need

　　Basic Qualifications:

　　Bachelor’s Degree in Engineering, Science discipline or equivalent.

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

　　2+ years of experience in new product/process development - experience in new product development with knowledge in design controls and associated regulations ISO 13485, device cGMP 21 CFR 820, etc.

　　Preferred Qualifications:

　　Experience in developing and managing suppliers and supplied processes/products – onboarding, development, qualification – including activities such as PPAP and supplier audit

　　Experience in process risk management documentation pFMEA & PCP development

　　Highly proficient in all aspects of Validation – Process & Test method validation (minimum 5 years experience as a practitioner).

　　CQE, Lean, or OpEx certifications.

　　Experience successfully creating/managing a talented, engaged and performing team.

　　CSV a plus.

　　Experience developing additively manufactured product,

　　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, experience with supplier audits a plus.

　　Knowledge in selection & development of inspection techniques – automated inspection techniques such as CMM and vision systems a plus.

　　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.