VP, QA Franchise (Med Device)

Position Summary:

Responsibilities: Essential Duties

• Provide strategic leadership for all franchise Quality Assurance functions to ensure compliance with global medical device regulations, including 21 CFR 820, ISO 13485, EU MDR, CMDR, CFDA, and PMDA.
• Ensure medical devices are designed, validated, manufactured, and distributed in accordance with Design Control requirements, risk management principles (ISO 14971), and BBMI quality standards.
• Partner with Business Unit leadership to integrate quality and regulatory expectations into product development, manufacturing operations, and lifecycle management.
• Represent Corporate Quality in franchise leadership forums, design reviews, manufacturing site assessments, and cross‑functional project teams for device programs.
• Develop, maintain, and report medical device–specific quality metrics (e.g., NC/CAPA trends, complaint rates, audit findings, field actions) to drive continuous improvement across the QMS.
• Provide executive‑level reporting on device quality performance, compliance risks, manufacturing site status, and key project milestones.
• Coordinate FDA‑required and global post‑market surveillance activities, including complaint handling, vigilance reporting, trend analysis, and field corrective actions, in partnership with Corporate PMS.
• Champion a strong medical device quality culture and support harmonization of a unified corporate QMS across all device operations and manufacturing sites.
• Develop and manage the franchise quality budget, including staffing, operational expenses, supplier quality oversight, and special compliance or remediation projects.
• Serve as the primary liaison with regulatory authorities during medical device inspections, audits, and communications related to product quality, compliance issues, and site performance.
• Partner closely with Regulatory Affairs, Engineering, and R&D to ensure that process development, and manufacturing adhere to quality standards.

Expertise: Knowledge & Skills

• Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
• Directs the activities of broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees. Determines actual organizational structure and allocation of resources.
• Judgement is required in resolving complex problems based on experience.
• Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• Minimum of 10 years related experience required, with at least 7 years of quality management experience required.
• Applicable industry/professional certification preferred.
• Occasional business travel required

Salary range is $260,000-$290,000/annually

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

#IND123