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
- Tuition Reimbursement
- Employee discounts at local retailers
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