Vice President of Quality

Connect Life Science Ltd; San Francisco (CA); Hybrid; USD 250,000 - 350,000; Full time

Job summary

Connect Life Science Ltd in the Bay Area seeks an experienced Vice President of Quality to lead quality operations as new products advance to commercialization. This leadership role oversees quality assurance and regulatory compliance across development and post-market stages.

The successful candidate will bring extensive medical device quality leadership, deep regulatory knowledge (ISO 13485, FDA 21 CFR Part 820), and a proven record of guiding products from development to market.

Qualifications

• Extensive experience in quality leadership within the medical device industry.
• Expertise in regulatory compliance, risk management, and quality systems (ISO 13485, FDA 21 CFR Part 820).
• Proven experience bringing products from development to market.
• Strong leadership, communication, and problem-solving skills.

Responsibilities

• Oversee quality systems and ensure compliance with FDA, ISO, and other regulatory standards.
• Lead quality initiatives from product development through to commercialization.
• Manage internal and external audits, corrective actions, and continuous improvement efforts.
• Collaborate cross-functionally with R&D, Manufacturing, and Regulatory teams.
• Provide strategic direction to ensure successful product launches and post-market support.

Skills

Quality leadership

Regulatory compliance

Risk management

ISO 13485

FDA 21 CFR Part 820

Product development

Job description

Bay Area, CA - Hybrid working 3 days p/w on site

Competitive Salary & Benefits Package

A rapidly growing medical device company, is seeking an experienced Vice President of Quality to lead their quality operations as they advance new products to commercialization. This key leadership role will be responsible for overseeing all aspects of quality assurance and regulatory compliance (not affairs/submissions), ensuring the highest standards throughout product development and commercialization.

You should have a proven track record in the medical device industry, with strong expertise in quality systems, FDA regulations, ISO standards, and bringing products to market. Strong leadership, strategic vision, and experience working in a fast-paced, highly regulated environment are essential.

Key Responsibilities:

• Oversee quality systems and ensure compliance with FDA, ISO, and other regulatory standards.
• Lead quality initiatives from product development through to commercialization.
• Manage internal and external audits, corrective actions, and continuous improvement efforts.
• Collaborate cross-functionally with R&D, Manufacturing, and Regulatory teams.
• Provide strategic direction to ensure successful product launches and post-market support.

Qualifications:

• Extensive experience in quality leadership within the medical device industry.
• Expertise in regulatory compliance, risk management, and quality systems (ISO 13485, FDA 21 CFR Part 820).
• Proven experience bringing products from development to market.
• Strong leadership, communication, and problem-solving skills.