Stryker Operations Quality Mgr in Redmond, Washington

Requisition ID 29164BR

Job Title Operations Quality Mgr

Group MedSurg and Neurotech

Division Medical

Business Function Quality Assurance

Country United States

State/Province WA

City Redmond

Employment Category Full Time

Percent Travel Required Up to 10%

Shift 1st

About Stryker

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 All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. We are an EO employer – M/F/Veteran/Disability.

Job Description / Information

GENERAL SUMMARY:

Responsible to lead and manage a group of Quality professionals to ensure a high level of Quality Management System and regulatory compliance in the plant. This position will be responsible for maintaining Quality Management System in the areas of nonconforming product, Calibration Lab management and Manufacturing Quality Engineering. Serves as management representative in these areas in the absence of the Sr. Quality Manager.

MAJOR DUTIES/RESPONSIBILITIES:

  • Coordinate Management Review activities related to nonconforming product, Calibration Lab and Manufacturing Quality.

  • Perform annual performance reviews and recommend appropriate salary action.

  • Ensure QMS system compliance with applicable regulatory and statutory requirements.

  • Provide support for Corrections and Corrective Actions related to Manufacturing issues.

  • Ensure effective closure to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited during audits.

  • Ensure training requirements are completed on time.

  • Conduct and support benchmarking activities.

  • Identify areas of opportunity and support continual improvement of the Quality Management System.

  • Identify, develop, and report QMS metrics.

  • Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of division’s continual improvement initiatives

Minimum Qualifications

BASIC QUALIFICATIONS

  • BS degree in Engineering or other relevant field

  • 7+ years’ experience in Quality related field within medical device or other regulated manufacturing environment (biotech, pharma, military/space, etc).

  • 2+ years of experience managing a team.

PREFERRED/DESIRED QUALIFICATIONS

  • Master's Degree or equivalent additional coursework.

  • Certification as ASQ Certified Quality Engineer and/or Certified Manager of Quality /Operational Excellence preferred.

  • Demonstrated use of Quality tools/methodologies and project management skills.

  • Support compliant execution of quality-related activities, including but not limited to CAPA, change management, problem solving, product and process development, acceptance activities

  • Management of professional level quality staff preferred.

  • Demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as Microsoft Project.

  • Develop and execute strategy for improving production quality system capability and performance

  • Demonstrated experience in developing quality management systems; design and development of training programs/courses; lean documentation; and Six Sigma methodology.

  • Demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military/space).

  • Applied understanding of CGMPs, ISO 9001, ISO 13485, MDSAP and CMDR

  • Demonstrated ability to effectively advocate a strategic quality systems approach and lead the organization to compliance.

  • Ensure a culture of partnership, transparency, service and collaboration exists between Global Quality, Divisions and Operations.

  • Demonstrated leadership ability and experience.

  • Demonstrated PC proficiency.

  • Demonstrated organizational and written/verbal communication skills.

  • Demonstrated ability to self-motivate

  • Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.

  • Demonstrated ability to prioritize tasks in a deadline-driven environment.

WORKING CONDITIONS:

  • Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Generally involves sitting most of the time.

  • Must be able to communicate with large groups of people.

  • Must be able to review printed materials).

  • 10% travel may be required.

All 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