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Software Quality Manager

Flex

This is a Full-time position in Austin, TX posted June 20, 2021.

* CURRENT EMPLOYEES :Please click here to be redirected to the internal career site.Job DescriptionThe Software Quality Manager will be based in Austin, Texas. The Software Quality Manager will be lead a group of software validation and quality engineers to ensure software developed and used for medical device manufacturing process are appropriately verified and validated and meet the internal SOP and FDA regulatory requirements.We are looking for someone who demonstrates:* Intense collaboration* Passionate customer focus* Thoughtful, fast, disciplined execution* Tenacious commitment to continuous improvement* Relentless drive to winHere is a glimpse of what you’ll do:* Develops and initiates standards and methods for inspection, testing and evaluation*Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.* Develops, implements and coordinates product assurance program to prevent or eliminate defects in new or existing products* Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.* Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals.* Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program.* Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.* Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.* Interface with customers on technical/quality issues and improvement initiatives.* Responsible for managing customer audits and regulatory/compliance agency audits.* Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.* Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards.* Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.* Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industryHere is some of what you’ll need (required):* Must have extensive experience on software validation/verification activities from Medical Device/Pharma industries.* Must have extensive experience on MES and ERP system.Here are a few of our preferred experiences:* BS in Engineering or similar degreeHere 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 retailersFG40Job CategoryQualityIs Sponsorship Available?NoFlex 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: accessibility@flex.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.

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