Machine Shop Quality Manager

Randstad USA; Union City (CA); On-site; USD 130,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Quality Control

CNC

Machine Shop

Mechanical Inspection

Zeis Calypso

PC-DMIS

CMM

CMM Programming

Education

High School

Tools

PC-DMIS

Zeiss Calypso

Job description

Randstad is recruiting a seasoned Quality Manager on behalf of a leading precision manufacturing client. In this role, you will take full ownership of the quality management system (QMS), quality assurance operations, and inspection processes across the facility. You will lead cross-functional compliance initiatives, drive continuous improvement, manage customer and registrar audits, and mentor a high-performing quality team in a fast-paced manufacturing environment.

Qualifications

• Experience: 10+ years of progressive operational and quality leadership experience in a precision manufacturing environment (medical device, aerospace, or precision machining preferred).
• QMS & Auditing Expertise: Proven track record managing ISO 9001 and ISO 13485 systems (21 CFR 820 familiarity is a plus); ISO Lead Auditor or AS9100 Lead Auditor certification preferred.
• Technical Skills:Background in statistical process control (SPC) using Minitab, root-cause investigation (CAPA/NCR/Change Control), and supplier quality monitoring.
• Metrology & Inspection (Plus): Hands-on experience with Coordinate Measuring Machine (CMM) programming and operation (e.g., PC-DMIS, Calypso) is strongly preferred.
• Education: Bachelor’s degree in Engineering, Quality Assurance, Operations Management, or related technical discipline strongly preferred.
• Software Proficiency:Proficiency in Microsoft Office (Excel, Word, PowerPoint); familiarity with SolidWorks and ERP/QMS software platforms is a plus.
• Physical Requirements: Ability to navigate a manufacturing floor and office environment, lift up to 25 lbs. regularly (occasionally up to 50 lbs.), wear required PPE, and stand or walk for extended periods during inspections and audits.

salary: $130,000 - $150,000 per year
shift: First
work hours: 7 AM - 4 PM
education: High School

Responsibilities

• Quality Systems & Compliance: Maintain and enhance the QMS in compliance with ISO 9001, ISO 13485, and ITAR regulations; guide strategic initiatives for future quality certifications.
• Audits & Governance: Oversee the internal audit program, host customer and third-party registrar audits, and lead executive Management Review meetings.
• Customer Quality Assurance: 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.
• Validation & Operations Support: Oversee validation documentation (IQ/OQ/PQ) for equipment and critical processes; partner with production to optimize plant layout, process capabilities, and direct labor efficiency.
• Continuous Improvement: Spearhead operational excellence initiatives using Lean, 5S, DMAIC, and Kaizen methodologies to minimize scrap and reduce cost of quality.
• Team Leadership & Development: Recruit, train, supervise, and mentor quality assurance and inspection personnel; establish departmental goals, KPIs, and performance reviews.
• Budget & Departmental Administration: Manage departmental operating budgets, monitor capital expenditure plans, and enforce workplace safety and OSHA standards.

Skills

• Quality Assurance
• Quality Control
• CNC
• Machine Shop
• Mechanical Inspection
• Zeis Calypso
• PC-DMIS
• CMM
• CMM Programming

Qualifications

• Years of experience: 0 years
• Experience level: Manager

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Experience

• Manager

Education

• High School