Dosimetry Laboratory Supervisor
3 weeks ago
Job Posting Start Date Job Posting End Date
FLEX Inc is seeking a highly skilled Dosimetry Laboratory Supervisor to join our team in Austin, TX.
The successful candidate will be responsible for planning and directing activities related to the establishment and maintenance of ISO 9000 requirements and other quality programs.
Key responsibilities include:
- Supporting electron beam IQ/OQ/PQ validations
- Performing dosimetry laboratory equipment validations
- Conducting routine dosimetry testing and data analysis
- Performing dosimeter batch calibrations and dosimeter batch calibration verification audits
- Troubleshooting dosimetry spectrophotometers and spectrometers and associated computer software
- Collecting, reviewing, and analyzing dosimetry results to support irradiation process
- Authoring, reviewing, and executing validation protocols for dosimetry laboratory equipment and test methods
- Performing review of test data with application of GDP
- Will be required to perform change requests when required and complete them in a timely manner
- Authoring, reviewing, and revising 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
- Ensuring 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
- Ensuring personal training requirements are met and that training records are current
- Coordinating activities within the organization in support of ISO 9000 requirements
- Conducting internal audits & process audits
- Coordinating the corrective action system, driving internal and external issue resolution
- Coordinating the customer satisfaction program, SCARS analysis and corrective actions
- Serving as customer liaison for the quality function
- Preparing analysis of and reports on audit results
The ideal candidate will have:
- 5 years of dosimetry experience
- 3+ years of leadership experience
- Previous FDA regulations experience
- Medical device industry and ISO13485 experience preferred
- E-beam sterilization experience preferred
FLEX Inc offers a comprehensive benefits package, including medical benefits, dental, vision, life insurance, matching 401K, PTO, tuition reimbursement, and employee discounts at local retailers.
FLEX Inc 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.
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