Lead Technician in Salt Lake City, UT at Stryker Corporation

Date Posted: 9/17/2018

Job Snapshot

Job Description

The Lead Technician will be primarily responsible for the sterility compliance of Stryker's product in accordance with relevant regulatory requirements and standards for medical devices. The Lead Technician will work with the Microbiologist to ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilization processes and associated utilities.


Will work within the microbiology team, under general supervision, with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following:

  • Environmental monitoring of clean-rooms for viable air, viable surface and particulate in line with ISO 14644 standards.
  • Monitoring of utilities including all grades of water, and where necessary, compressed air.
  • Co-ordination of samples for bioburden and endotoxin testing.
  • Ordering consumables (media etc) and general stock for day-to-day running of laboratory.
  • Performing sampling for validations and re-qualifications as required.
  • Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
  • Input to NC and CAPA generation and resolution within the Microbiology group and across related business units. Competency into correction of NCs.
  • Performs sterility release review.
  • Proficient in local procedures and practices.
  • Represent QA as the first point of contact for daily line support issues.
  • Work with QE’s and product teams to identify areas for risk reduction and error proofing processes and work on implementation of these.

Education and Qualifications:

  • Associate degree in Microbiology or equivalent with 2 years of experience in a quality discipline or 4 years of experience in a Microbiology Discipline

       and

  • Experience in a Quality/Regulatory Affairs environment desirable.
  • Ability to build knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
  • Must possess strong communication skills as well as have the ability to manage multiple tasks simultaneously.
  • Strong interpersonal skills.
  • Demonstrated ability to work independently.
  • Ability to be proficient in statistical techniques, data review and analysis.
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages

Work From Home: No

Travel Percentage: None

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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