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We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

This is a 23 month Fixed Term Contract

Key areas of responsibility ​

• Work closely with operations and the business functions to ensure quality performance of product and processes. (SGS).

• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues. (DD).

• Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.

• Initiates and leads in the development and improvement of the manufacturing processes for existing products. (SGS).

• Oversight and leads investigations during concession management. (SGS).

• Review and approval of change management activities, challenges effectiveness and drives strong review.

• Interpret KPI trends, drive continuous improvement process.

• Advocate of Human Factor practices, proficiency in the science of identification of mitigation.

• Subject matter expert in risk management practices and concepts.

• Develop and provide input by identifying opportunities and weaknesses.

• Proficiency in and provides technical direction in optimization of inspection methods and sampling.

• High proficiency in statistical methods and application.

• Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.

• Aids in the development of validation strategies for existing products. (SGS).

• Support manufacturing transfers to other plants/facilities, leading quality activities. (SGS).

• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.

• Coach and mentor others in quality topics and activities.

Education / work experience

• BS in a science, engineering or related discipline.

• MS, CQE, or CRE preferred.

• Six Sigma Green or Black belt preferred.

• Minimum of 5 years experience preferred.

Knowledge / competencies

• Previous industry experience required.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.

• Understanding of US and International Medical Device Regulations.

• Familiarity with ISO 13485, GDP, GMP required.

• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

• Ability to represent Quality function within and across project teams.

• Strong interpersonal skills, written, oral communication and negotiations skills.

• Strong in critical thinking and ""outside the box"" thinking.

• Highly developed problem solving skills. Strong analytical skills.

• Demonstrated ability to successfully manage and complete projects in a matrix organization.

• Demonstrated ability to work independently and as part of cross-functional teams.

• Experience in working in a compliance risk situation.

• Computer literacy.

• Some travel may be required.

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 150 million patients annually.

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.