Senior Quality Engineer

Work Flexibility: Onsite

Stryker is hiring a Senior Quality Engineer to support our Global Quality Operations team, working within our Trauma & Extremities business in Arlington, TN! 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.

What you will do:

• Provide engineering expertise in quality assurance, control, and prevention, driving continuous improvement in internal products and processes.
• Address and resolve supplier quality issues affecting daily operations, ensuring minimal disruption and compliance with standards.
• Advocate for and lead projects that enhance quality performance for internal processes and customer satisfaction.
• Ensure alignment with industry regulations and standards while maintaining high-quality manufacturing practices.
• Work with Divisional QA, suppliers, and cross-functional teams to resolve top quality issues, managing internal and supplier non-conformances and CAPAs.
• Maintain KPIs, analyze trends, and implement corrective actions to monitor and improve process and product quality.
• Engage in optimizing internal manufacturing processes, including process and equipment validation/qualification and MSA.
• Support analysis of manufacturing-related complaints and product field actions while driving initiatives to reduce defects and enhance overall site QA activities.

What you will need:

Basic Qualifications:

• Bachelors degree in a science or engineering related discipline.
• Minimum of 2+ years of experience as an Engineer in the areas of quality, manufacturing or operations within a highly regulated industry in following cGMP and GDP regulations.

Preferred Qualifications:

• Understanding of US and International Medical Device Regulations, with familiarity in ISO 13485 with experience in a medical device, pharmaceutical, or biopharmaceutical industry.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Six Sigma Green or Black belt preferred.

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.