Quality Manager

Proven Recruiting; San Diego (CA); On-site; USD 140,000 - 145,000; Full time

Benefits offered by this job

401(k) Matching

Job summary

Proven Recruiting represents a medical technology manufacturer seeking a Quality Manager in San Diego, CA. You will lead Quality Operations, drive QMS and ISO 13485 readiness on the production floor, and shape transformation across QA, QC, and Quality Engineering teams.

You will oversee CAPA, deviations, audits, supplier quality, and risk management while building a high-performance team of up to 24 professionals. This on-site role offers strong benefits and growth opportunities.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Quality, or a related field.
• 5+ years of experience in Engineering and/or Quality within a regulated manufacturing environment, preferably medical devices or diagnostics.
• Experience overseeing both Quality Assurance (QA) and Quality Control (QC) functions.
• Strong expertise in quality systems, risk management, CAPA, nonconformance management, root cause analysis, supplier quality, and audit readiness.
• Proven leadership experience developing teams, driving change, and improving quality and compliance performance.

Responsibilities

• Lead Quality Operations and the Quality Management System (QMS), ensuring compliance with regulatory, customer, and business requirements.
• Manage and develop Quality Assurance, Quality Control, and Quality Engineering teams while supporting quality activities on the production floor.
• Manage up to 24 people on Quality team.
• Drive the site's quality transformation initiatives, including strengthening systems, processes, and readiness for ISO 13485 implementation.
• Oversee CAPA, deviations, complaints, nonconformances, change controls, supplier quality, and quality risk management programs.
• Lead audits, inspections, management reviews, and cross-functional continuous improvement initiatives to enhance quality performance and customer satisfaction.

Skills

QA Leadership

QA & QC oversight

QMS & CAPA

Root Cause Analysis

Supplier Quality

Audits & Compliance

Team Leadership

Education

Bachelor's degree in Engineering/Quality

Job description

Quality Manager, Medical Device, San Diego, CA. $140,000-$145,000

Are you a hands-on Quality leader with medical device or diagnostics experience who knows how to build teams, strengthen quality systems, and drive change? Our client, an innovative medical technology manufacturer, is seeking a Quality Manager to lead a critical function during a period of transformation, with the opportunity to help elevate the site from ISO 9001 to ISO 13485 standards.

Who you are:

• Bachelor's degree in Engineering, Manufacturing, Quality, or a related field.
• 5+ years of experience in Engineering and/or Quality within a regulated manufacturing environment, preferably medical devices or diagnostics.
• Experience overseeing both Quality Assurance (QA) and Quality Control (QC) functions.
• Strong expertise in quality systems, risk management, CAPA, nonconformance management, root cause analysis, supplier quality, and audit readiness.
• Proven leadership experience developing teams, driving change, and improving quality and compliance performance.

What you'll do:

• Lead Quality Operations and the Quality Management System (QMS), ensuring compliance with regulatory, customer, and business requirements.
• Manage and develop Quality Assurance, Quality Control, and Quality Engineering teams while supporting quality activities on the production floor.
• Manage up to 24 people on Quality team.
• Drive the site's quality transformation initiatives, including strengthening systems, processes, and readiness for ISO 13485 implementation.
• Oversee CAPA, deviations, complaints, nonconformances, change controls, supplier quality, and quality risk management programs.
• Lead audits, inspections, management reviews, and cross-functional continuous improvement initiatives to enhance quality performance and customer satisfaction.

Why work here:

• High-visibility leadership role with significant impact across the organization.
• Opportunity to rebuild and strengthen a quality organization during a transformational period.
• Direct influence on the site's transition from ISO 9001 to ISO 13485.
• Strong benefits package, including employer 401(k) contributions and matching that can total approximately 10%.

What does this position pay?

Compensation is determined by several factors which may include skillset, experience level, and education. The expected range for this role is $140,000-$145,000 per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community.