Dosimetry Lab Supervisor

Job Posting Start Date 10-07-2024 Job Posting End Date 11-25-2024

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Dosimetry Lab Supervisor in Austin, Tx.

Reporting to the Quality Manager, the Dosimetry Lab Supervisor plans and directs activities concerned with the establishment and/or continuance of ISO 9000 related requirements and other quality programs. Plans and coordinates internal process audits and ensures optimization of the corrective action system within the operation and with external customers and vendors.

E shift - 600a-600p Sun,Mon,Tue,every other Wed

What a typical day looks like:

• Support electron beam IQ/OQ/PQ validations.
• Perform dosimetry laboratory equipment validations.
• Perform routine dosimetry testing and data analysis.
• Perform dosimeter batch calibrations and dosimeter batch calibration verification audits.
• Troubleshoot dosimetry spectrophotometers and spectrometers and associated computer software.
• Collect, review and analyze dosimetry results to support irradiation process.
• Author, review and execute validation protocols for dosimetry laboratory equipment and test methods.
• Perform review of test data with application of GDP.
• Will be required to perform change requests when required and complete them in a timely manner. Author, review and revise dosimetry work instructions including, but not limited to, operation and calibration.
• Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations into Alert/OOL excursions.
• Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines.
• May be required to generate, execute and summarize special laboratory studies.
• Ensure personal training requirements are met and that training records are current.
• Coordinates activities within the organization in support of ISO 9000 requirements.
• Conducts internal audits & process audits.
• Coordinates the corrective action system, driving internal and external issue resolution.
• Coordinates the customer satisfaction program, SCARS analysis and corrective actions.
• Serves as customer liaison for the quality function.
• Prepares analysis of and reports on audit results.

The experience we're looking to add to our team:

• 5 years of dosimetry experience.
• 3+ years of leadership experience
• Previous FDA regulations experience
• Medical device industry and ISO13485 experience prefer
• E-beam sterilization experience prefer

What you'll receive 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
Quality

Is Sponsorship Available?
No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate 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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [email protected] and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).