Director of Quality

Skills Alliance; California (MO); On-site; USD 120,000 - 200,000; Full time

Job summary

A dynamic organization in the MedTech industry seeks a Director of Quality to lead their quality function. This role involves overseeing compliance with regulations, driving continuous improvement initiatives, and mentoring the quality team to ensure operational excellence.

Qualifications

• 10+ years of progressive quality experience, including 5+ years in a leadership role.
• Deep knowledge of QMS principles and regulatory requirements.

Responsibilities

• Lead the Quality department, including QA, QC, and Compliance teams.
• Develop and maintain a comprehensive Quality Management System (QMS).
• Mentor and develop quality team members, fostering a proactive culture.

Skills

Problem-Solving

Analytical

Communication

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Job description

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Job Title: Director of Quality

Location: Irvine, CA

Employment Type: Full-Time

Confidential - (Medical Device)

Adynamic and growth-oriented organization based in Irvine, CA, delivering high-impact solutions across the MedTech industry that has a strong commitment to innovation, operational excellence, and customer satisfaction, are seeking a seasoned leader to direct and scale their Quality function to meet evolving regulatory, operational, and strategic goals.

Position Overview:

The Director of Quality will lead and oversee all aspects of the company’s quality strategy, ensuring product and process compliance with applicable regulations and standards. This role is responsible for driving continuous improvement initiatives, maintaining certifications, and fostering a culture of quality throughout the organization.

Key Responsibilities:

• Lead the Quality department, including Quality Assurance (QA), Quality Control (QC), and Compliance teams.
• Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with industry standards (e.g., ISO 9001, ISO 13485, FDA, etc. as applicable).
• Serve as the primary quality liaison for regulatory bodies, customers, and internal stakeholders.
• Collaborate cross-functionally to support new product development, supplier qualification, and risk management.
• Oversee internal and external audits, CAPAs, and non-conformance investigations.
• Track and report key quality metrics; use data to drive continuous improvement efforts.
• Ensure compliance with all relevant quality and safety regulations across operations.
• Mentor and develop quality team members, fostering a proactive and accountable quality culture.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 10+ years of progressive quality experience, including 5+ years in a leadership role.
• Deep knowledge of QMS principles and regulatory requirements relevant to the company’s industry.
• Proven success leading audits and achieving/maintaining certifications.
• Strong problem-solving, analytical, and communication skills.
• Experience in a fast-paced, mid-size organization is preferred.

Please reach out to [e-mail] for further information.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Medical Equipment Manufacturing

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