Work Flexibility: Hybrid

Stryker is hiring a STAFF QUALITY ENGINEER for our Global Quality Operations division in Durham, NC. As a Senior Quality Assurance Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.

Who we want:

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

• Collaborate with operations and other business functions to develop and improve processes for quality products.
• Lead NC/CAPA containment, root cause investigations, and implementation of corrections and corrective actions.
• Change management execution of internal quality deliverables associated with engineering changes, manufacturing transfers, and supplier-initiated changes.
• Monitor KPIs, perform analysis, and interpret trends for process/product quality improvements.
• Develop understanding of risk management practices/concepts and apply knowledge to manufacturing operations.
• Engage and interface in internal and external audits providing subject matter expertise.
• Process and equipment validation/qualification as well as Measurement System Analysis.
• Drive continuous improvement actions to reduce manufacturing defects.
• Provide leadership and subject matter expertise in QA activities to the overall site.
• Apply statistical methods of analysis and process control to current operations.
• Review/approve batch records, calibration records, and other QMS records.
• Support and drive human factor practices, familiarity in the science of human factor identification, reduction, and mitigation.

What you need

Required

• Bachelor’s degree
• 4+ years working in a highly regulated environment (FDA, ISO 13485, etc.).

Preferred

• Bachelor’s degree in Engineering or Science.
• 2+ years’ experience in quality, engineering, manufacturing and/or operations working within medical device or pharmaceutical industry.
• Knowledge of FDA QSR, ISO 13485, ISO 14971 etc.
• Knowledge of Quality Concepts (e.g., Risk Management, CAPA, Audits, Statistics, GDP, GMP).
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Possesses a CQE or similar certification, 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.