Senior Quality Engineer

Work Flexibility: Onsite
Stryker is hiring a Senior Quality Engineer to support our Trauma & Extremities business! As a Senior Quality Engineer, you will provide quality leadership and direction in quality assurance, control, and preventative activities within operations with a focus on preventative measures and continuous improvement of products and processes.
You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Your aim is to always ensure compliance to regulations and standards, as well as find the best quality solution to support priorities for the business. The successful candidate should be flexible to support internal issues/projects and to support supplier-related topics depending on business needs.
Stryker Trauma & Extremities is the primary site of the Foot & Ankle and Biologics market segments, which are among the fastest-growing segments in Orthopedics.
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.
• Collaborative Partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• 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.

What you will do:
You 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 operations and business functions to ensure the quality performance of products and processes.
• Initiates and leads in the development and improvement of the manufacturing processes for existing and new products.
• Review and approval of change management activities, challenges change effectiveness, and drives strong review.
• Interpret KPI trends, and take action as necessary, driving a continuous improvement process.
• Responsible for initiation, management, and support of ship, product Holds, and potential product escapes.

What you need:
Required

• Bachelor's degree in Engineering
• Minimum 2+ years of working in a regulated environment.

Preferred

• Medical device or pharmaceutical industry experience is preferred.
• Working knowledge of ISO13485, 21 CFR Part 820 Quality Systems preferred
• Existing knowledge on internal and external audits and supplier relations and readiness.
• Knowledge of metrology tools, inspection techniques, engineering drawings, GD&T (Geometric Development and Tolerance).
• Ability to building strategic working relationships, while developing and using collaborative relationships to facilitate the accomplishment of work goals.
• Ability to make effective and timely decisions, efficiently prioritizing and executing tasks in a high-pressure environment.
• Skilled at working within a team-oriented/collaborative environment across teams to complete tasks successfully.
• Strong analysis and problem-solving skills including statistics, capabilities, validations, sampling planning, risk assessment.

Travel Percentage: 10%
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.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.