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Senior Project Manager, RAQA
- Stryker (Portage, MI)
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**Stryker** is hiring a **Senior Project Manager - RAQA** to support our digital health portfolio QMDS projects and will engage in the execution on the Medical Divisions Quality Plan and Regulatory deliverables for our global business. You will ensure on-time and on-budget delivery of high-profile strategic projects/initiatives which enable global market expansion and compliance with regulatory requirements for the digital portfolio.
**Workplace Flexibility & Location requirements:** This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA or Portage, MI. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.
What you will do:
Divisional Quality Plan & RAQAC PMO
+ Owns and execute multiple projects as part of the digital health QMS expansion.
+ Builds successful working relationships with internal and external personnel in various departments and sites across the globe.
+ Drive results in support of the business, even in the face of demanding timelines. Steps up to take on additional responsibility where appropriate.
+ Lead communication of project updates, priorities, and discussions to engage key stakeholders on the ongoing performance of projects and priorities the Division is responsible for.
+ Has the ability to influence without direct authority in a way that makes others want to be on their team.
+ Can understand and communicate how goals fit into broader organizational goals and prioritize tasks/schedules accordingly.
+ Exercises good judgment and can weigh benefits and risks to make solid decisions despite ambiguity.
+ Ability to learn quickly and adapt to a changing environment.
Divisional Quality System & Process Ownership Platform
+ Support the administration of the Process Ownership Platform which may include identification of new process owners, training process owners, and facilitating process owner forums to ensure an efficient and effective quality system across all division sites.
+ Partner with other departments (e.g., R&D, RA, Operations, Operations Quality, Supplier Quality, Approvals) to develop and deploy the divisional quality system.
+ Provide leadership and engagement with business partners across the Medical Division to foster collaboration across our global business and ensure effective and compliant quality system processes.
What you need
+ Bachelor’s Degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.
+ 6+ years of experience required; practical project management experience preferred.
+ Experience in FDA or Highly regulated environment preferred.
+ PMP certification or equivalent preferred.
+ Growth mindset – ability to learn quickly and adapt to a changing environment
+ Demonstrated ability to plan, track, facilitate, and close projects using applicable tools (Gantt, Burn downs, etc.) on time, within budget, and while controlling scope
+ Excellent interpersonal communication, collaborative team work, and negotiation skills
Preferred
+ Experience with software development lifecycle processes, and familiarity with digital health technologies, cloud platforms, and mobile solutions.
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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required 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.
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