What are the responsibilities and job description for the VP of Quality position at JJ SONIK?
Vice President of Quality – Medical Device
Location: West Coast (Relocation Required)
Position Overview:
We are seeking an experienced Vice President of Quality to lead and drive the quality strategy for our medical device organization. This executive-level role is responsible for ensuring regulatory compliance, product quality, and customer satisfaction across all non-manufacturing quality functions, including Quality Systems, Supplier Quality, Design Quality, and Post-Market Surveillance. The VP of Quality will work closely with executive leadership to align quality initiatives with business objectives and enhance the company’s reputation for excellence in the medical device industry.
Key Responsibilities:
- Develop and execute a comprehensive quality strategy aligned with corporate goals to support regulatory compliance and business success.
- Oversee and manage all aspects of quality, excluding manufacturing quality, including Quality Systems, Supplier Quality, Design Quality, and Post-Market Surveillance.
- Ensure compliance with FDA, ISO 13485, MDR, and other global regulatory requirements.
- Lead quality initiatives that drive product reliability, safety, and customer satisfaction.
- Serve as the primary point of contact for regulatory bodies and key customers regarding quality-related matters.
- Collaborate with R&D, Regulatory Affairs, Operations, and Commercial teams to integrate quality into product development and lifecycle management.
- Establish and monitor key quality metrics to drive continuous improvement.
- Lead efforts to improve supplier quality and ensure a robust supplier qualification and audit process.
- Develop and implement risk management strategies to mitigate quality and compliance risks.
- Champion a culture of quality and compliance across all levels of the organization.
- Prepare and oversee audits, both internal and external, ensuring the company maintains an exemplary regulatory standing.
- Drive digital transformation and innovation within the quality function to enhance efficiency and compliance.
Qualifications and Experience:
- Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- 15 years of progressive quality leadership experience in the medical device industry.
- Deep knowledge of global medical device regulations, including FDA, ISO 13485, MDR, and related standards.
- Demonstrated success in leading quality organizations and implementing best-in-class quality strategies.
- Strong experience in Design Quality, Post-Market Surveillance, Supplier Quality, and Quality Systems.
- Proven track record of engaging with regulatory agencies and managing successful audits.
- Ability to collaborate cross-functionally and influence decision-making at the executive level.
- Strong leadership skills with the ability to build and mentor high-performing teams.
- Experience with digital quality systems, data analytics, and leveraging technology for quality improvement.
- Willingness to relocate to the West Coast.
Work Environment:
- Executive-level role with a mix of office-based leadership and travel for site visits, supplier audits, and regulatory engagements.
- High visibility within the company and the medical device industry, requiring exceptional communication and strategic thinking.
- Travel required for regulatory interactions, supplier oversight, and company-wide quality initiatives.
