Senior Quality & Compliance Manager - Precision Manufacturing

Randstad USA; Union City (CA); Presencial; USD 130.000 - 150.000; Tempo integral

Resumo da vaga

Randstad is recruiting a seasoned Quality Manager to take full ownership of the QMS, QA operations, and inspection processes across the facility. You will lead audits, mentor a quality team, and drive continuous improvement in a fast-paced manufacturing environment.

The role requires 10+ years in quality leadership in precision manufacturing, ISO 9001/13485 experience, and expertise in SPC, CAPA, and CMM/PC-DMIS. On-site work in a high-tech setting with standard fast-paced shifts.

Qualificações

• 10+ years in quality/operational leadership in precision manufacturing (medical device/aerospace preferred).
• ISO 9001 and ISO 13485 QMS ownership with audit experience; Lead Auditor cert preferred.
• SPC, CAPA/NCR/Change Control, supplier quality monitoring knowledge.

Responsabilidades

• Maintain and enhance the QMS in compliance with ISO 9001, ISO 13485, and ITAR regulations.
• Oversee internal audits and host customer and registrar audits, and lead Management Review meetings.
• Track customer requirements, manage complaint investigations, lead root-cause analysis (CAPA, 5-Why, 8D), and ensure timely resolution of nonconformances to target 100% lot acceptance and on-time delivery.
• Oversee validation documentation (IQ/OQ/PQ) for equipment and critical processes; partner with production to optimize plant layout, process capabilities, and direct labor efficiency.
• Spearhead operational excellence initiatives using Lean, 5S, DMAIC, and Kaizen to minimize scrap and reduce cost of quality.
• Recruit, train, supervise, and mentor quality assurance and inspection personnel; establish departmental goals, KPIs, and performance reviews.
• Manage departmental operating budgets, monitor capital expenditure plans, and enforce workplace safety and OSHA standards.

Conhecimentos

Quality Assurance

Quality Control

CNC

Machine Shop

Mechanical Inspection

Zeis Calypso

PC-DMIS

CMM

CMM Programming

Formação

High School

Ferramentas

PC-DMIS

Zeiss Calypso

Descrição da vaga

Randstad is recruiting a seasoned Quality Manager to take full ownership of the QMS, QA operations, and inspection processes across the facility. You will lead audits, mentor a quality team, and drive continuous improvement in a fast-paced manufacturing environment.

The role requires 10+ years in quality leadership in precision manufacturing, ISO 9001/13485 experience, and expertise in SPC, CAPA, and CMM/PC-DMIS. On-site work in a high-tech setting with standard fast-paced shifts.