Hands-on Quality Manager — ISO 9001/13485 & CAPA Leader

Contract Professionals, Inc.; Hayward (CA); On-site; USD 130,000 - 155,000; Full time

Job summary

Contract Professionals, Inc. is seeking an experienced Quality Manager to lead quality systems in a precision manufacturing environment in Hayward, CA.

This hands-on leadership role collaborates with Operations, Engineering and senior leadership to ensure products meet customer, regulatory and quality requirements. The successful candidate will manage the QMS, lead ISO 9001 and ISO 13485 compliance, oversee audits, CAPA and nonconformances, and mentor the quality team on continuous improvement

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing or related field.
• 7+ years of progressive quality experience within manufacturing.
• Quality leadership or management experience.
• Strong working knowledge of ISO 9001; ISO 13485 experience preferred.
• Experience with CAPA, RCA, audits, nonconformance management and continuous improvement.
• Experience in highly regulated/controlled manufacturing environments is desirable.
• Cleanroom experience is a strong plus.
• Strong communication and leadership on the manufacturing floor.
• Hands-on and visible on the shop floor.

Responsibilities

• Lead and maintain the company's Quality Management System (QMS).
• Ensure ISO 9001 and ISO 13485 compliance.
• Support quality requirements within a controlled manufacturing environment.
• Lead internal and external audits and close findings timely.
• Manage CAPA, nonconformances, root cause investigations and corrective actions.
• Utilize problem‑solving methodologies including 5‑Why, Fishbone and 8D.
• Oversee incoming, in‑process and final inspection activities.
• Monitor quality metrics and drive continuous improvement.
• Partner with Manufacturing and Engineering to resolve quality issues.
• Support document/change control and quality record requirements.
• Develop and improve quality procedures and work instructions.
• Provide leadership and coaching to Quality team members.
• Promote a practical, collaborative approach to quality.

Skills

ISO 9001

ISO 13485

QMS leadership

CAPA management

Root cause analysis

8D problem solving

Audit management

Cleanroom manufacturing

Education

Bachelor's degree in Engineering, Quality, Manufacturing or related

Job description

Contract Professionals, Inc. is seeking an experienced Quality Manager to lead quality systems in a precision manufacturing environment in Hayward, CA.

This hands-on leadership role collaborates with Operations, Engineering and senior leadership to ensure products meet customer, regulatory and quality requirements. The successful candidate will manage the QMS, lead ISO 9001 and ISO 13485 compliance, oversee audits, CAPA and nonconformances, and mentor the quality team on continuous improvement