Senior Staff Engineer, Quality

Posted 5 Days Ago
Be an Early Applicant
3 Locations
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Senior Staff Engineer, Quality will provide quality leadership and direction within operations, manage quality initiatives, mentor the quality team, ensure compliance with regulations, and lead internal and external audits. The role emphasizes problem-solving and expertise across quality-related areas.
Summary Generated by Built In

Work Flexibility: Onsite

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. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

What you will do:

  • 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.

What you will need:

  • Level 8 Degree
  • 6 years experience

Travel Percentage: None

The Company
HQ: Kalamazoo, MI
51,000 Employees
On-site Workplace
Year Founded: 1941

What We Do

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 www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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