At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives. Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Sterilization Engineer located in Austin, TX
Reporting to the Sterilization Lab Manager, the Sterilization Engineer role will be responsible for coordination and implementation of in-house E-Beam Sterilization equipment and processes. This includes validation and sustaining processes to support sterilization activities.
What a typical day looks like:
- Write, review and approve qualification documents to support Sterilization Validation and re-validation activities for New Product Introduction and Sustaining in accordance with FDA/AAMI/ISO/EN guidelines/standards.
- Actively participate during all phases of sterilization qualification.
- Evaluate projects, provides guidance and technical information to others, generate protocols, execute qualification activities, analyze resulting data and prepare reports.
- Lead all assigned qualification activities.
- Determine and establish requirements for qualification activities.
- Make independent decisions related to qualification activities.
- Participate in the generation and/or update of the validation plan and validation status lists.
- Review qualification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
- Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
- Bring critical exceptions or deviations to management's attention and propose compliant solutions.
- Lead trouble shooting activities for E-Beam deviations and non-conformances
- Recommend to management as to the acceptance and release of qualified systems.
- Initiate and enforce necessary improvements and corrections; attend team meetings pertinent to validation.
- Write and revise standard operating procedures describing validation principles and activities.
- Provide E-Beam training and guidance to applicable operators and technicians
- Initiate, execute, and track completion of Change Control requests.
- Establish priorities and schedule activities to ensure timelines and milestones are met.
- Oversee contractors ensuring that they have the appropriate skill set and required training and are meeting performance expectations.
- Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
- Assures data availability and integrity for all quality related data. Consolidates and reports quality results.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Assists with development and implementation of quality audits.
- Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Analyzes reports and returned products and recommends corrective action.
- Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.
- Approves product, process and equipment qualifications Provides liaison to various regulatory bodies
The experience we're looking to add to our team:
- B.A. or B.S. in Microbiology, Engineering, Chemistry, or related field
- Minimum 6 years of experience in sterilization experience.
- Knowledge of the regulatory and cGMP regulations for medical device manufacturing operations, and validation procedures and practices.
- Excellent verbal and written communication, interpersonal and communication skills required.
- Demonstrated ability to develop and present site-wide training sessions.
- Demonstrated knowledge of E-Beam sterilization science
- Knowledge of statistics
What you'll receive for the great work you provide:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
HL45Job Category Quality
Is Sponsorship Available?NoFlex 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 recruitment process. Please advise us of any accommodations you may need by e-mailing: email@example.com.
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