Flex Job - 30156732 | CareerArc
  Search for More Jobs
Get alerts for jobs like this Get jobs like this tweeted to you
Company: Flex
Location: Austin, TX
Career Level: Mid-Senior Level
Industries: Technology, Software, IT, Electronics


Job Description

The Sterilization Laboratory Manager will be based in Austin, TX. In this role you will be responsible for supervising lab techs and analysts to ensure Quality/Compliance, product testing, cleanroom environmental monitoring objectives, validation and product release goals are met. This includes maintaining quality engineering programs, standards and improvements within the organization.

We are looking for someone who demonstrates:

  • Intense collaboration
  • Passionate customer focus
  • Thoughtful, fast, disciplined execution
  • Tenacious commitment to continuous improvement
  • Relentless drive to win

Here is a glimpse of what you'll do…

  • Manage the Sterilization team to ensure that bioburden, endotoxin, and sterilization activities are performed following customer requirements
  • Review, analyze, disposition, and develop when needed: Endotoxin/LAL data/test method, to support sterilizing processes
  • Responsible for investigation and recommendation of corrective actions in the event of out-of-specification and out-of- trend results
  • Support Validation activities (IQ/OQ/PQ), including protocol review, for various lab equipment, product, process, system, test method, sterilization, cleaning, equipment qualifications, and instrumentation in accordance with site procedures and industry guidelines (USP, ICH, ISO, and FDA)
  • Manage the environmental monitoring schedule for ISO 8 cleanrooms, identify negative trends, and implement corrective actions to ensure environmental specifications are met
  • Serve as the Facility Radiation Safety Officer (RSO), to ensure that the E-Beam is operating following the safety, environmental, and procedural requirements
  • Develop and initiate standards and methods for inspection, testing and evaluation
  • Analyze reports and returned products and recommend corrective action

Here is some of what you'll need (required)…

  • Minimum 5+ years' laboratory experience
  • Minimum 2+ years' managerial or supervisory experience
  • Experience with FDA regulations and other medical device and international standards
  • Bachelor's degree in Microbiology or related field
  • Demonstrated knowledge of E-Beam sterilization science
  • Demonstrated knowledge of dosimetry, bioburden, endotoxin, and environmental monitoring

Here are a few examples of what you'll get for the great work you provide…

  • Full range of medical benefits, dental, vision
  • Life Insurance
  • Matching 401K
  • PTO
  • Tuition Reimbursement
  • Employee discounts at local retailers
Job Category OperationsFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: accesibility@flextronics.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.

The information we collect:

We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. Your details will be provided to the entity you are applying for a job with. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier. We will process your data in accordance with our Recruitment Privacy Notice.

If you have any queries about the processing of your data, please contact:

Global Data Privacy Officer:

Email Address: chiefprivacyofficer@flex.com

 Apply on company website