We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually, as well other great perks. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)

Stryker is hiring a Senior Quality Engineer in Durham, North Carolina to support the Craniomaxillofacial (CMF) Division. In this role, you will provide quality engineering support and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. In addition, you will advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers, while ensuring compliance to regulation and standards.

The preferred experience for this position would involve familiarity with various areas, such as environmental monitoring, method validation, sterilization techniques, cleanroom operations, and/or endotoxin testing.

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• 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.

What you will do:

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

• Oversight of NC/CAPA, activist and mentor in problem-solving and root-causing activities.

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

• Review of change management activities.

• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.

• Proficient understanding of risk management practices and concepts.

• Develop and provide input by identifying opportunities and weaknesses.

• Proficient in statistical methods and application.

• Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.

• Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes. (SGS).

• Coach and mentor others in quality topics and activities.

What you need:

Required:

• Bachelor’s degree in a science, engineering or related discipline required.

• 2+ years of related experience.

Preferred:

• MS, CQE, or CRE preferred.

• Previous industry experience desired (Validation, Sterilization, Clean Room GMP, QMS Compliance Audits).

• 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 desired.

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

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

• Experience in working in a compliance risk situation.

• Highly developed problem-solving skills

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.