Director- Quality Systems & Compliance

Fenwal is a global leader in medical technologies focused on improving blood safety and availability for patient care.  A $600+ million business, Fenwal is a growing company that develops leading products, services and technologies used to collect, process and store blood and its vital components.    Over 4000 people around the world work for Fenwal, helping each day to improve people’s lives while developing a rewarding career.

We currently have an opportunity for a Director, Quality Systems & Compliance with global responsibility for maintaining a rigorous regulatory compliance program for the corporation to ensure all worldwide regulatory requirements are constantly met. This position will manage the Document Control function, internal audit program, employee training and facilitate third party inspections.

• Represent the company during external inspections by 3^rd parties such as TuV/ISO
   inspections, FDA, ARC, BioMat, LifeSource, etc.
• Develop and implement internal Quality/Regulatory documentation processes to meet FDA, ISO, JPAL, CMDR and other worldwide regulatory compliance requirements. 
• Develop and implement a cross functional internal audit program/team to ensure all worldwide regulatory requirements are met at the manufacturing plants and distribution centers.
• Lead and provide expert advice in the areas of compliance QSR, JPAL, CMDR, ISO13485. 
• Monitor and report on all regulatory compliance activities within the business units.
• Support assigned due diligence and new business integration activities as required.
• Support Fenwal QMS initiatives to drive simplification and standardization throughout the organization.
• Manage overall coaching, training, development and succession plans for the team.

• BS in Science or Engineering and Lead Auditor certification or ASQ Professional Certification
• 6 - 10  years of quality/regulatory compliance experience in the medical device and/or pharmaceutical industry
• 7 years management experience in dealing with FDA and other regulatory bodies. 
• Quality systems expert with knowledge of QSRs, ISO, MDD,JPAL and CMDR     requirements
• Experience in transfusion medicine and/or blood technologies preferred.
• Proven success managing Regulatory Compliance situations with ISO, FDA and other 3^rd party auditors
• Understanding of Lean Manufacturing
• Strong leadership skills and demonstrated success in managing a diverse team
• Experience with Access data bases, Excel, Word
• Excellent interpersonal/communication/influencing/negotiation skills required
• Demonstrated strong analytical and problem solving skills
• Excellent verbal and written communication skills
• Ability to work independently or in group setting, excellent organizational skills
• Ability to travel 30% both US and International

Fenwal, Inc. offers an excellent salary and benefits package including immediate medical, dental and vision coverage, as well as life insurance, disability, 401K with company match and profit sharing.

Fenwal is an Equal Opportunity Employer. We encourage and support a diverse workforce.