Sr. Manager, Sterilization & Microbiology in Kalamazoo, MI at Stryker Corporation

Date Posted: 2/21/2020

Job Snapshot

Job Description

Who we want

  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
  • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
  • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

What you will do

The Senior Manager, Sterilization & Microbiology will lead and develop a team of 4-7 microbiologists while ensuring completion of all microbiological and bio-analytical testing. You will be responsible for special project/protocol testing in timely and appropriate manner for all assigned sites.

  • Ensuring product disposition plan attainment, and that all products released meet the pre-determined quality requirements for all assigned sites.
  • Managing the Sterilization Controls Subsystem related activities for all assigned sites.
  • Partnering with Site/Divisional Business Quality Leads to ensure all local related quality metrics are met.
  • Manage the Sterility Assurance teams for all assigned sites to continuously fully comply with all quality and regulatory standard requirements.
  • Assist during implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOP and specifications
  • Monitor the testing techniques and accuracy of all records and documentation that are done in the microbiology laboratory.
  • Initiate pro-active functions to impact production, increase efficiency in micro lab, solve problems generated during sterilization validation, improve and provide new product support in ECA and micro testing. 
  • Evaluate performance via performance appraisal and ensure employees development plan is discussed as part of annual performance review. Conduct at least quarterly group meeting with entire Sterility Assurance, micro and quarantine service units and discuss future challenges.
  • Ensure that all documentation is prepared, reviewed and revised, as required including sterilization protocols, ECA excursions, micro investigation, TI and specifications.
  • Establish environmental objectives and targets for his/her area that will provide continuous environmental improvements for all assigned sites.
  • Combine regulatory guidelines with actual test results and practices to create knowledge for advancing quality improvement initiatives.
  • Supervises directly the Sterility Assurance Advisor and the Microbiology Laboratory and Product Disposition personnel for all assigned sites.
  • Coaches and develops direct report subordinates.
  • Is responsible for inter-departmental compliance with company policies and corrective actions for all assigned sites.

What you need

  • Bachelor’s degree in science, Microbiology or biological science preferred.
  • Masters degree desirable
  • 10+ years of experience in microbiology lab in medical device or pharmaceutical.
  • ISO Lead Auditor training, desirable.
  • Certified Quality Engineer (ASQ), desirable.

Work From Home: Remote

Travel Percentage: 30%

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.

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