Stryker Manager, Manufacturing Quality in Minnesota

Job Summary:

The Manager of Manufacturing Quality will lead quality engineering support for process development, manufacturing and the supply chain to assure that the quality system requirements for product realization are in conformance with Stryker and Entellus Quality Management System. In addition to supervising quality engineers and inspectors, the manager work directly with the process development and manufacturing team to drive new product introduction and to foster continuous improvement of the operation.

Responsibilities:

• Manage daily support of manufacturing operations and lot release.

• Design experiments, develop protocols, perform process validation and data analysis, draw conclusions and communicate results.

• Provide quality engineering support for process development and manufacturing of medical devices, including combination products. Where appropriate, disposition nonconforming product.

• Provide trending for manufacturing scrap and nonconforming product

• Approve receiving inspection paperwork. Where appropriate, disposition nonconforming product.

• Maintain contact with vendors, and provide feedback to suppliers regarding performance and compliance to specifications

• Represent the Quality organization on process and/or design changes from verification to product implementation in manufacturing

• Document corrective and preventive action requirements, determine the root cause, determine the corrective action required, and monitor for effectiveness

Qualifications:

• BS degree in a scientific or engineering discipline

• Minimum 1-3 years in a supervisory capacity

• Minimum 5 years of experience in quality engineering with manufacturing support in the medical device or pharmaceutical industry.

• Must demonstrate knowledge of medical device and pharmaceutical GMPs, and ISO standards applicable to the FDA and international regulatory agencies

• Experience supporting processing operations related to polymer chemistry, lyophilization, device assembly and packaging, and sterilization.

• Must have strong knowledge of manufacturing process controls, including analytical test methods and cleaning verification/validation.

• Superior time management, with the ability to work on several projects simultaneously in a fast-paced environment.• Excellent communication skills required

Work From Home: No

Travel Percentage: Up to 25%

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com