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Austin, TX Full Time Posted by: Flex Posted: Friday, 11 June 2021

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Job Description

The Director of Quality [Medical] will be based in Austin, Texas. As Director of Quality you will be responsible for developing, implementing and coordinating product quality assurance program(s) to prevent or eliminate defects in new or existing products through the development and management of people and processes.

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

  • May be appointed as Management Representative for Medical Quality Requirements
  • Responsible for ISO 13485 Certification and FDA Regulatory Requirements
  • Surveys and evaluates future and current vendors.
  • Prepares and implements QA Policies and Procedures.
  • Reviews discrepancy reports and implements corrective actions.
  • Reports progress to customers as required. Maintains contact with customers to ensure their business needs are met or exceeded.
  • Conducts presentations to staff as required.
  • Establishes QA objectives and creates plan of action.
  • Cooperates with top management personnel in formulating and establishing company policies, operating procedures and goals.
  • Evaluates content of reports from product assurance program department heads and confers with top management in formulating fiscal budget for product assurance program.
  • Confers with engineering about quality assurance of new products designed and manufactured.
  • Reviews technical publications, articles and abstract to stay abreast of technical developments in industry.
  • Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.

Here is some of what you'll need

  • 10+ years of prior work experience in manufacturing in medical related industries
  • 10+ years of quality experience, with a minimum of 5 years in management. Most recent 3 years of experience must be in Medical related manufacturing (Pharma, Med Device, etc)
  • Deep understanding of quality system requirements
  • ISO13485, ISO9001, FDA 21CFR part 820, GMP; MDD would be a plus
  • Strong Team development and management skills to enable the creation of a highly capable and sustainable Quality Functioning Team
  • Demonstrates ability to analyze and determine methods and procedures
  • Ability to prioritize competing commitments in line with departmental and/or corporate objectives
  • Proficient in Microsoft Office and database management tools

Here are a few of our preferred experiences

  • Minimum education of Bachelor's degree

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
  • Free Tracking Attendance
  • Tuition Reimbursement
  • Employee discounts at local retailers


Job Category

QualityRelocation:Eligible for domestic relocation only

Is Sponsorship Available?


Flex 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: (see below) 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.

Austin, TX, United States of America
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6/11/2021 3:59:56 PM

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