Job Details

Position Title: Quality Manager

Immediate Supervisor: Executive Owner

General Purpose:

This key leadership position is responsible for leading all aspects of Quality processes and systems, managing the Quality Management System (QMS), internal and external audits, regulatory and safety compliance, and leading a team of Quality Technicians, Process Engineers and Learning and Development Coordinators in a manufacturing environment. The role collaborates with cross-functional teams to drive continuous improvement, ensure product integrity, and exceed customer expectations. This role is with a small, family-owned contract manufacturing company that is rapidly expanding, fueled by New Product Introductions and the development of full-scale production capabilities.

Responsibilities:

QUALITY MANAGEMENT

Customer Response Team:

• Serve as the primary point of contact for quality-related communications with customers and suppliers.
• Manage customer complaints, lead investigations, and coordinate timely, effective resolution.

Manage ISO Certification

• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable customer/regulatory requirements.
• Own Document Control for QMS and production documents (Work Orders, labels, Certificates of Conformance, inspection forms), ensuring revision control, approvals, controlled release, and record retention.
• Lead internal and external audits (customer, supplier, registrar), including audit preparation, execution, follow-up, and reporting to the Executive Team.
• Own the metrology and test equipment program (calipers, gauges, vision systems, clean room monitoring equipment, etc.), including calibration/verification, status control, and records management.
• Oversee equipment qualifications and process validations to ensure ongoing compliance and product integrity.

Manage Quality Assurance Processes

• Drive robust Root Cause Analysis and CAPA execution for internal and external nonconformances.
• Lead and develop the Quality team, including supervision of Quality Technicians and daily quality execution on the production floor.
• Manage supplier quality performance, including supplier evaluations, audits, incoming quality issues, and nonconformance resolution.
• Maintain clean room quality standards, environmental controls, and monitoring/testing protocols.
• Assess quality organizational needs and build a high-performing team aligned with business growth and customer requirements.

CONTINUOUS IMPROVEMENT

• Lead and oversee the company's Continuous Improvement (CI) program to drive process optimization, quality performance, and operational excellence.
• Partner cross-functionally to identify improvement opportunities, implement solutions, and sustain gains.
• Partner with company leadership to define quality strategy, establish KPIs, and drive continuous improvement.
• Evaluate and implement best practices, tools, technologies, and systems that strengthen quality, compliance, and manufacturing capability.
• Develop, maintain, and enforce manufacturing SOPs, work instructions, and standard work to ensure consistent execution and training alignment.
• Identify and mitigate operational risks affecting product quality, safety, delivery performance, and regulatory/customer compliance.
• Manage organizational safety programs, including compliance with the IIPP (Injury and Illness Prevention Program) and related safety requirements.

LEARNING AND DEVELOPMENT

• Lead and oversee company-wide training and employee development programs, including the implementation, development, and leadership of quality- and safety-related training, to support performance, compliance, and organizational capability, and ensure employees are competent to perform assigned duties and meet QMS requirements.
• Administer the Learning Management System (LMS), maintaining current training content, training matrices, and complete/accurate training records to support audits and continuous improvement.

Education / Experience:

• Bachelor's degree in a quality, manufacturing, engineering, or medical device related field.
• 4+ years in a Quality leadership role within a manufacturing environment.
• 3+ years managing a QMS within ISO 13485 or other ISO Standards within a manufacturing environment, and leading customer/supplier audits.
• Proven experience with precision component manufacturing and contract manufacturing environments.
• Hands-on experience with CAPA, root cause investigations, and quality metrics.
• Familiarity with medical device manufacturing and regulated industries (Preferred).
• Familiarity with applying principles of Lean Manufacturing, Theory of Constraints and/or Six Sigma Problem Solving.

Qualifications:

• Proficient in interpreting engineering drawings and using inspection equipment.
• Strong organization and communication skills; experience delivering training.
• Comfortable working independently and leading small teams.
• Ability to effectively serve as the primary point of contact for all quality-related communications.
• Aptitude for working within a small family business environment where responsibilities and priorities can change quickly.
• Spanish-speaking ability (Preferred).
• Must be available for full-time, on-site work in San Carlos, CA.

Physical demands:

• Combination of office and plant production floor presence for supervision, inspections, and clean room management.
• Ability to sit at a desk for periods of time for planning and reporting.
• Ability to stand and walk for extended periods on the plant floor.
• Operate standard office equipment and hand controls.
• Ability to occasionally lift up to 20 pounds (e.g., supplies, production files).
• Observe visually distance, color, periphery and depth; ability to adjust focus.

What We Offer:

• Full time permanent role with competitive salary and benefits (medical, dental, vision, 401(k) + matching)
• $110,000 - $140,000 per year
• Opportunity to grow within a technically advanced converting business working with top-tier customers and materials

**Disclaimer: This job description may not be inclusive of all assigned duties/responsibilities or aspects of the job, and additional duties/responsibilities may be assigned from time to time as necessitated by business demands and/or operational considerations at the sole discretion of the Employer. This job description does not constitute a contract of employment and the employment relationship between Employee and Employer is at-will.