• Responsible for oversight of quality operations at multiple sites to ensure adherence to applicable regulations, improved efficiency and harmonization
• Act as a leader in the Quality organization, helping define and drive the Quality vision, mindset, and culture.
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
• Ensure the QARA systems are designed and function to enable sustainable service and product quality, and are following all applicable current standards
• Works with business stakeholders to identify areas for harmonization and efficiencies
• Manages all quality data for the global business units and provides visibility to trends and/or deficiencies where applicable
• Develops an in-depth understanding of existing processes, the needs of clients, and the needs of strategic partners to identify opportunities for process improvement and the tools necessary to both implement and measure plans of correction through direct engagement and analysis of data
• Establishes or re-engineers processes to improve operational efficiency and minimize technical difficulties. Quickly identifies solutions to problems and assures corrections are expeditiously implemented
• Diligently mentors and develops staff, through regular communication of vision, priorities, and complex operational requirements
• Develop budget for department and ensure adherence to the budget

Qualifications:

• Travel up to 25% (to facilities in the US and Canada)

• Strong ability to build effective teams and develop talent

• Ability to influence quality culture across diverse teams

• Clear and concise verbal and written communication

• Knowledge of Human Cell and Tissue Products subject to Section 361 of the Public Health Act

• Familiarity with regulations pertaining to Laboratory Developed Tests (CLIA, CAP, NYSDOH, IVDR)

• Detail-oriented with the ability to troubleshoot and resolve problems

• Minimum of 8 years of experience in Quality Management/Quality Systems/ Audit Program Management

• Strong organizational and interpersonal skills

• BS Degree in Life Science, Engineering or equivalent program is preferred

• ASQ certification and some level of Six Sigma training strongly preferred

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.