Job Title: Director Product Quality
Location: San Diego, CA
Type: Direct Hire
Compensation: $200 - $240K + Bonus
Work Model: Onsite
Hours: 40.0
Overview
We are seeking an experienced
Director of Product Quality to lead and strengthen our
Quality Engineering and
Quality Control (QC) functions. This strategic leadership role is responsible for driving product quality excellence across new product development, manufacturing, supplier quality, and sustaining operations. The ideal candidate will be a hands-on quality leader with deep expertise in quality systems, root cause investigations, CAPA, validation, risk management, and statistical analysis within the
IVD, Medical Device, or Pharmaceutical industries. The successful candidate will bring a strong background in
Quality Engineering and
Quality Control (QC). along withproven people
leadership experience
Responsibilities
- Lead, develop, and mentor the Product Quality organization, including Quality Engineering for new product and sustaining activities and Quality Control teams focusing on Incoming and QC Lab final Inspection, and Quality Release
- Partner closely with Manufacturing, R&D, Operations, Supply Chain, and site Quality leadership to drive quality performance and business results
- Play a critical role in strengthening root cause analysis, improving CAPA effectiveness, and building organizational capability in structured problem solving
- Build high-performing teams with clear accountability, strong technical capability, and a continuous improvement mindset
- Establish effective goals, metrics, and operating mechanisms for the Product Quality function
- Champion the use of appropriate analytical and statistical techniques across the organization to support informed decision making, root cause analysis, and proactive risk mitigation
- Lead cross functional, high impact quality initiatives, provide deep technical guidance, and ensure alignment between quality objectives and broader business goals
- Drive continuous improvement initiatives for manufacturing processes, identifying and addressing quality issues through root cause analysis, corrective and preventive actions (CAPA), and statistical process control
- Serve as the site's subject matter expert on statistical tools and methodologies
- Oversee the application of quality engineering principles in product design and development, including design controls, risk management, and design validation activities
- Collaborate with Supply Chain and R&D to establish and maintain a robust supplier management program, including supplier selection, auditing, and performance monitoring
- Ensure departmental and site wide activities are conducted in full compliance with applicable regulatory requirements, industry standards, and internal quality systems
- Support internal and external audits
- Work with Quality Leadership to establish priorities and goals for risk management, failure analysis, process validation, process capability, trend analysis, statistical quality control and process control
- Serve as a point of contact for complex or high-risk quality issues and decisions
Requirements
- Bachelor's Degree required; Engineering degree preferred; minimum of 15 years relevant work experience including in-depth experience in Quality Engineering (QE) and Quality Control (QC)
- Minimum 10 years supervisory experience
- Experience from the In Vitro Diagnostics (IVD) industry preferred, but open to Medical Device and Pharma
- Hands-on role with expert knowledge of Quality Engineering principles including risk management, root cause investigation, and descriptive and inferential statistics
- Strong hands-on validation experience (process validation, software validation, CAPA processes)
- Expert knowledge of quality analysis tools such as cause-and-effect diagrams, Pareto charts, run charts, scatter diagrams, and regression analysis
- ASQ Certified Quality Engineer required
- Strong statistical tools experience, managing and personally utilizing data analysis tools
- Experience working with Cartridges & Assays is a plus
- Six Sigma Black Belt certification is a plus
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
#M3
Ref: #558-Scientific
