Vice President of Quality and Regulatory Compliance

Prescott's, Inc. is a premier medical device company dedicated to the distribution and refurbishment of multiple types of medical devices including surgical microscopes, pumps, monitors, sterilizers and anesthesia machines. With a commitment to delivering high-quality and reliable products, Prescott's strives to ensure that healthcare professionals have the tools necessary for optimal patient care. Our integrated services encompass equipment repair, maintenance, and management solutions, ensuring our clients have access to state-of-the-art technology.

As the Vice President of Quality and Regulatory Compliance, you will spearhead the initiative to maintain and enhance the quality standards across all Prescott's operations. This critical role involves developing comprehensive quality management systems, overseeing regulatory compliance, and fostering a culture of continuous improvement within the organization. You will be responsible for ensuring that Prescott's products meet both customer expectations and regulatory requirements while driving innovation and efficiency.

Your leadership will be essential in executing the company's vision for quality, collaborating closely with various departments to establish quality assurance protocols and regulatory strategies that comply with industry standards. The Vice President of Quality and Regulatory Compliance will report directly to the CEO and play an instrumental role in shaping the company's strategic direction.

This position is available for work in Monument/Denver, CO, Kansas City, MO, or remotely.

Responsibilities

• Develop and implement a comprehensive quality management system that aligns with company goals and regulatory requirements
• Oversee the regulatory compliance framework, ensuring adherence to industry standards such as ISO 13485, FDA regulations, The Joint Commission, DNV and other applicable legislation
• Lead the Quality Assurance team, providing direction and support in continuous improvement initiatives
• Establish quality metrics and key performance indicators (KPIs) to monitor system effectiveness and drive improvements
• Collaborate with cross-functional teams to identify quality issues and facilitate the resolution of non-conformance
• Drive the development and implementation of training programs focused on quality and compliance for all employees
• Lead internal auditing activities as required by the Quality Management System at all sites including conducting opening and closing meetings. Maintains annual audit schedule. Assures all findings are addressed within 30 days and sees through to completion including follow up. May assist other audits
• Act as the liaison with regulatory agencies, managing submissions, audits, and inspections
• Serves as document control administrator for all quality documentation as it relates to ISO including Quality Manual, QOPs, Work Instructions, Forms and Records.
• Monitors complaint activities to ensure they are addressed/closed before the review takes place for the period in which they occurred as required
• Conduct risk assessments and develop plans to mitigate identified risks related to product quality
• Stay informed on industry trends, regulatory changes, and best practices in quality management
• Provide and deliver periodic updates to executive leadership regarding the progress of quality and compliance initiatives, which encompasses risk assessments and enhancements
• Champion a corporate culture that prioritizes quality and regulatory adherence in all organizational processes
  
  
  

Requirements

• Bachelor's degree in engineering, life sciences, or a related field; advanced degree (MBA or MS) preferred. Years of experience can be used in lieu of degree.
• 10 years of experience in quality assurance and regulatory compliance role, with at least 5 years in a leadership position
• In-depth knowledge of quality management systems, ISO standards, and FDA regulations
• Relevant certifications such as ASQ CQE, CQA, RAC, or similar are highly desirable
• In-depth knowledge of applicable regulatory requirements and standards (e.g., FDA, ISO 9001, ISO 13485, The Joint Commission, DNV and other regulatory agencies)
• Experience with QMS implementation and management
• Familiarity with risk management principles (e.g., ISO 14971)
• Demonstrated experience in developing and implementing successful quality programs
• Strong leadership skills with the ability to motivate and inspire a diverse team
• Exceptional analytical and problem-solving capabilities
• Excellent communication and interpersonal skills, with proficiency in stakeholder engagement
• Proven track record of managing audits and regulatory inspections, ensuring compliance with applicable regulations
• Ability to thrive in a dynamic and fast-paced environment
• Ability to travel 25% to various locations within the United States
• Annual salary ranges from $120,000 to $125,000, complemented by a 20% Manager's Incentive Plan
  
  
  

Benefits

At Prescott's, we prioritize your well-being and growth with a comprehensive benefits package including PTO, medical, dental, and vision coverage, as well as a 401K plan with company matching. But we don't stop there - we're committed to your continuous learning and development, offering opportunities for training, workshops, and certifications. Our fun and inclusive work environment celebrates diversity and fosters growth, making every day an opportunity to thrive.