Senior Quality Engineer

Work Flexibility: Onsite

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.

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

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.