Senior Staff Quality Engineer

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

The Role:

The successful candidate will provide quality leadership and technical guidance on preventative quality within operations and other business functions at local and global level, advocating and leading the execution of initiatives & projects to enhance quality performance within the business. They will mentor and provide technical direction across multiple areas of expertise, as well as ensuring compliance to regulation and standards.

What You Will Do:

• Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
• Work closely with business functions assess, provide oversight and direction on quality performance of product and processes.
• Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
• Coach and mentor the quality team and others business functions in quality topics and activities, with several topics at expert level.
• Leads / Manages quality initiatives / projects at local & global level.
• Recognized process owner in areas of expertise. Expertise across multiple areas from the following, problem solving, risk, concession & change management, lean, six sigma, CAPA, statistics, validation, inspection processes & sampling etc.
• Input into local, global & corporate processes, a representative on review & discussion boards and teams for expert & valued input.
• Provides input / assessment and justification at expert level during concession / change management and quality issues. Review and approval of same driving strong review.
• Interpret KPI trends, take action as necessary, driving a continuous improvement process.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Oversight / deputise for audit management, logistics and preparation as required.
• Aids in the development of validation strategies, certified in multiple disciplines of validation to approval level.
• Support/ Leads manufacturing transfers to other plants/facilities, leading quality activities.
• Responsible for initiation, management and support of ship, product Holds, potential product escapes.
• Deputises proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis.

What You Will Need:

• Bachelor degree in Science, Engineering or equivalent/ related subject and 6 years of work experience in a quality discipline, or
• Masters of Science, Engineering or related subject with 4 years of experience
• PhD desirable

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com