Flex Job - 30443467 | CareerArc
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Company: Flex
Location: Plano, TX
Career Level: Mid-Senior Level
Industries: Technology, Software, IT, Electronics

Description

Job Description

The Sr. Director of Global Quality Systems is based in Austin, TX. The Sr. Director has responsibility for (1) providing strategic leadership in global quality activities to ensure continual compliance to US / international regulations and standards, (2) leading efforts to implement best in class quality systems procedures and practices, and (3) providing development and management of people and processes. This position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies.

This position may also be based in Buffalo Grove, IL, San Diego, CA or Plano, TX.

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…

  • Prepare and implement corporate quality management systems procedures and policies to ensure continual compliance with applicable US / international regulations and standards.
  • Promote the company-wide understanding of the QMS. Ensures that company employees are trained on applicable procedures, regulations, and standards.
  • Serve as business owner for QMS and document control software systems.
  • Review and assess the suitability and effectiveness of the quality system, including trending and performing data analysis
  • Develop and review quality system and product quality related metrics with senior management
  • Help drive a culture of quality and continuous improvement throughout the organization
  • Ensure sites have implemented effective compliance programs and are prepared for regulatory inspections, notified body audits, etc.
  • Lead preparation and management of external regulatory inspection activities. Interface with regulatory agencies (FDA), notified bodies (TUV), other competent authorities. Responsible for addressing audit findings, responses, and corrective and preventative actions.
  • Oversight of corporate internal and external audit programs and drive continuous improvements to corporate and local quality systems.
  • Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.​
  • Perform other duties as assigned by supervisor.

Here is some of what you'll need (required)…

  • A bachelor's degree in a related field
  • Minimum 8 years of management experience with a background in medical device manufacturing
  • Experience implementing and deploying Quality Management System software application tools
  • Thorough knowledge of applicable regulations (FDA, ISO 13485)
  • Strong experience with FDA inspections and audits, specifically site preparation and/or defending quality systems during inspections

Here are a few of our preferred experiences…

  • A Master's or MBA degree preferred
  • Experience implementing single quality management systems across multiple regulated sites
  • Experience doing quality training
  • Proven ability to work across cultures/poles/sites
  • Considerable experience presenting, interacting, and building effective relationships with internal management teams, customers, and regulatory agencies. Strong communication and presentation skills (articulate and persuasive)
  • American Society of Quality (ASQ) or Regulatory Affairs Professional Society (RAPS) certified
  • A technical/engineering/life sciences background preferred

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
  • PTO
  • Tuition Reimbursement
  • Employee discounts at local retailers
Job Category QualityFlex 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: accesibility@flextronics.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.

The information we collect:

We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. Your details will be provided to the entity you are applying for a job with. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier. We will process your data in accordance with our Recruitment Privacy Notice.

If you have any queries about the processing of your data, please contact:

Global Data Privacy Officer:

Email Address: chiefprivacyofficer@flex.com


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