Sterilization Engineer - Kalamazoo, MI - Stryker Corporation

Date de publication : 2/21/2020

Résumé de l'offre

Description de l'offre

Who we want

  • 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.
  • Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures
  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
  • Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

What you will do

As a senior level Sterilization Engineer you will lead the Sterility Assurance team to ensure compliance to ANSI/AAMI/ISO, FDA Quality System Regulation and ISO13485 related to medical device sterilization, microbiology and related product and manufacturing process controls.

  • Support the Sterility Assurance team to drive compliance to applicable FDA, ISO, ANSI/AAMI and company requirements, including all safety, quality and operational documentation and practices.
  • Provide knowledge and recommendations for processing products through ethylene oxide and gamma sterilization.
  • Merge cGLP, CGMP, ANSI, AAMI, ISO, FDA, EPA and USP guidelines with actual bioburden, cytotoxicity and bacterial endotoxin test results to create knowledge that is capable of innovatively advancing quality improvement initiatives that address sterility concerns on medical devices.
  • Review/approve product and sterilization process change control documentation and specifications.
  • Support all sterilization validations, dose audits, customer inquiries specific to sterilization and cleaning, residual evaluations, and all other processes that have the potential of negatively impacting product quality from a sterility, cleanliness or biocompatibility standpoint.
  • Provide guidance to team members to ensure understanding and achievement of Quality, Cost, Delivery, Safety and Talent objectives.
  • Support, mentor, and develop the performance of the team to drive and support a high performance work culture; including writing and delivering performance appraisals, administering disciplinary action, providing positive recognition, liaising with Human Resources to ensure consistency in administration and compliance with Company policies, focusing on the development of high potential employees and crafting succession plans, and establishing a collaborative environment that encourages and supports employee engagement.

What you need

  • Bachelor of Science in Biology, Microbiology or a closely related life science. Master’s Degree preferred.
  • 4+ years of medical device or pharmaceutical microbiological or biological testing, or research and development experience that includes product sterilization.
  • Applied knowledge of microbiological and sterilization concepts, practices, and procedures. These include gamma irradiation and ethylene oxide forms of sterilization.
  • Demonstrated knowledge of endotoxin and bioburden testing.
  • Ability to cross-reference and keep current on relevant ANSI, AAMI, ISO, USP, EPA, EU and related guidelines.
  • Demonstrated ability to work on cross-functional teams. Prefer experience leading project teams and using project management tools.
  • Prefer knowledge in analytical chemistry and cleaning validations.
  • Demonstrated ability to implement performance measures, drive team effectiveness and productivity, while maintaining high levels of employee engagement and morale.
  • Travel is limited to less than 25%.

Work From Home: Occasional

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.

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