Project Lead

Title: Project Lead (Remote)

Remote, United States

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:

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

Project Lead (Remote)

Stryker is hiring a Project Lead. As a Project Lead, you will be working in partnership with Global Supplier and Operations Network, this role is a Project Lead function that enables successful supplier changes and supplier projects by driving quality, cost transformation, time to market and service improvements for our customers whilst remaining compliant to both internal and external standards.

Who we want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do:

Will work within the Shared Services Global Team, responsible for related activities as it applies to Supplier Initiated Change Request (SICRs) and supplier projects, these include but not limited to the following:

• Support Organizational growth through demonstrating best in class Leadership Expectations
• Develop strong positive relationships with stakeholders to develop and maintain a best in class SICR program
• Lead selected projects to deliver high quality outcome meeting all related metrics and key process indicators (KPIs)
• Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as PPAP, FMEA, MSA’s, Validations and Qualifications.
• Reviewing and approving of Validation/Qualification Documentation
• Working with Subject Matter Experts, Consultants/Contractors, Suppliers, Divisional & Local resources as required ensuring that validations and change control activities are completed as per local, corporate, and divisional procedures
• Point of contact for SICRs in different GQO Manufacturing Sites and Divisions
• Enable successful completion of SICRs and supplier projects to achieve its quality, cost and time requirements
• Be able to identify SICRs quality risks/gaps and provide solutions to correct
• Technical Quality Expert that sets strategy by utilizing a risk based approach around PPAP, FAI’s, Inspection Certification, leveraging supplier testing, etc.
• Drive continuous optimization of SICRs Process
• Collect change requests from vendor and understand the status, priorities and assign for execution
• Work with Stryker Site team collecting inputs related to Specific SICRs, ECR generation
• Collaborate with vendor for getting the PPAP, MSA, GR&R & SICR activities in compliance
• Support and participate in Supplier change review board [SCRB] and assist in decision making for type of changes
• Conduct virtual audit and evaluation for Validation protocols & reports (IQ/OQ/PQ), Procedure changes

What you need:

Required Qualifications:

• Bachelor of Science, Engineering or related subject
• 6+ years of experience in validation, quality and project management.
• Experience working in regulated environment.

Preferred Qualifications:

• Masters of Science, Engineering or related subject in quality
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and machine tool fundamentals.
• Strong knowledge of Quality Concepts and Risk Based Techniques (e.g. FMEA, Risk, Statistics).
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Continuous Improvement Mindset
• Lean Six Sigma training a distinct advantage.
• Strong project management skills. Must demonstrated success in tracking and reporting out progress against defined goals to project stakeholders

$83,000.00 – $176,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.