Our client is a rapidly expanding medical device firm headquartered in Utah that carries the distinction of being the first orthopedic focused outsourcing company that provides a complete portfolio of services ranging from product innovation, to contract manufacturing and supply chain management. The organization has an experienced management team, a world-class corporate culture and an established reputation for being a leading innovator in the field. This is a unique opportunity for an executive that wants to put their drive and entrepreneurial initiative to work!

Job Responsibilities:
1) Report directly to the CEO and serve as a member of the Executive Leadership Team
2) Establish and maintain corporate systems for conformance to domestic and international quality standards as well as medical device laws and regulations
3) Formulate strategic and tactical plans and budgets to achieve company objectives with a significant focus on delivering top quality performance in the industry for the company
4) Contribute to the management planning process including the strategic and tactical plans and budget as well as ensure execution of the plans
5) Provide effective and efficient quality processes including procedures, documentation systems, tools, metrics needed to meet quality system standards and achieve company objectives
6) Ensure that the company is operating in accordance to quality standards and maintaining associated certifications as well as positive audit results
7) Ensure that the company is operating in compliance with applicable regulatory bodies, maintaining applicable registrations and positive audit results
8) Ensure that the company successfully passes customer audits to gain or maintain its status as an approved supplier
9) Provide quality and regulatory training to ensure awareness and understanding of regulations and quality standards
10) Serve as corporate liaison to regulatory and standards organizations
11) Ensure timely and effective communication to customers as needed on quality issues
12) Communicate and collaborate with all stakeholders of the business (employees, customers, suppliers, regulatory bodies, standards organizations and the Board of Directors)
13) Integrate quality systems across multiple divisions to establish a single corporate quality system
14) Implement a robust and efficient document control system
15) Institute dynamic control plans and process validation plans

Job Requirements:
1) Degree (4 year) in a relevant discipline (Master’s preferred)
2) Minimum 10 – 15 years of quality and regulatory experience in the medical device industry
3) Minimum 5 years of experience in leading quality and regulatory functions at the corporate or business unit level
4) Proven track record of leading a quality and regulatory organization to support a high growth business with industry leading quality performance
5) Record of making quality systems more efficient and robust
6) Excellent critical thinking and problem solving skills
7) Ability to lead people and get achieve results through others
8) Proven ability to develop high performance teams including the ability to mentor and coach

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03445.html