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Title: VP of Quality
Location: Vadnais Heights, MN
Shift: Day Shift (Monday – Friday)
Compensation: $170,000 + Bonus
Benefits: Company offers an exclusive benefits package including Medical, 401k, and PTO.
Vaccine Requirement: No COVID19 vaccine requirement.
Position Description: VP Of Quality
This VP of Quality position is responsible for ensuring company quality standards guarantee a world class quality operation. This VP of Quality will lead the organizations quality management program including implementation and management of the total quality system. It will establish and impose functional policies and make tactical decisions within overall strategic direction. This VP of Quality position will interpret, administer and have input on overall company policy. It will understand and comply with regulatory and safety items and standards. It must maintain compliance as a regulated organization and provide risk assessment for any and all deviations and opportunities.
Duties/Responsibilities include but are not limited to:
• Responsible for the leadership and development, coaching, mentoring, performance management and work direction of the Quality team.
• Quality System Management Representative
• Oversee or conduct internal and external audits.
• Evaluate and approve all corrective and preventative actions. (CAPA)
• Maintain compliance for GMP, ISO, and FDA.
• Responsible for the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company product.
• Meet or exceed company quality goals.
• Working with other departments, lead company through the changes necessary to elevate the organization to a premier "world class" medical manufacturer.
• Accountable for achieving company product and service quality is at or above company goal.
• Accountable for ensuring expense accounts that you have specific responsibility for are within dollar forecast YTD.
• ISO, regulatory and customer audits are passed with no major findings, based on current compliance.
• Accountable for timely completion of CCARs, SCARs and ACARs, including for CCARs communicating with customers, Sales and the President, a weekly status update of all open CCARs, including expected close date.
• Accountable for Vendor Quality Audits and SCARS.
• All process control you "Own" and your team "Own" have been reviewed and updated within the last 24 months.
• Accountable for performance management.
• Accountable for meeting or exceeding utilization requirements of the Recognition Program.
• Ensure all established learning and development for self and direct reports is current and up-to-date.
• Minimum 10 years experience in a medical manufacturing quality environment.
• Experience managing a medical manufacturing quality department.
• 4 year Bachelor's Degree, Quality Engineering Degree preferred
• Experience in performance management, training and development of others.
• Strong background in regulatory requirements such as ISO, GMP, CAPA and others.
• Experience in continuous improvement and lean manufacturing.
• Strategic planning and implementation skills.
• Experience in mentoring others to improve performance for reaching their individual career goals.
• Strong root cause analysis and problem solving skills at both a strategic and tactical level.
• Proficient PC skills to include Microsoft Office (Excel, Word, Outlook).
• A thorough understanding of medical manufacturing, its environment and protocol.
• Ability to accurately assess, develop, grow, reward and retain the talent of associates, while having the courage and the conviction to sensitively, professionally, and expeditiously move "C" players out of the organization.
• Independent and risk tolerant.
• Ability to effectively implement and execute.
• Strategic and tactical development and implementation.
• Ability to challenge existing assumptions.
• Excellent communication skills, written and verbal.
• Can speak, understand and write English.