Quality Assurance Manager

BioTalent; San Diego (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

BioTalent is seeking a senior leader to direct Quality Operations and the QMS at our San Diego site. This role provides strategic and operational leadership across QA and QC, driving continuous improvement, risk management, and supplier quality programs to meet regulatory and customer requirements.

You will partner with site leadership, coordinate audits, and report quality performance to executives while developing teams and sustaining a culture of prevention and excellence.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Quality, or a related field
• 5–7 years of experience in Engineering and/or Quality, preferably in medical device
• 3+ years in a supervisory or management role
• Experience with quality risk management principles in a regulated manufacturing environment
• Expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes
• Track record leading teams and driving continuous improvement in quality, compliance, and business performance
• Proficient in MS 365 applications
• Experience with ERP/MRP systems, electronic QMS (eQMS), and data analytics/reporting tools
• Comfortable working in both office and manufacturing environments

Responsibilities

• Own the QMS and Quality Operations, ensuring compliance with regulatory, customer, and business requirements
• Provide leadership, coaching, talent development, and performance management for QA/QC teams
• Develop and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality
• Establish quality objectives and KPIs aligned with business goals
• Lead quality risk management across products, processes, suppliers, and quality systems throughout the product lifecycle
• Ensure effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls
• Lead Management Reviews and report quality performance, compliance, risks, and improvement initiatives to executive leadership
• Direct internal, supplier, customer, certification, and regulatory audit programs, ensuring timely closure of findings
• Ensure audit readiness and lead Quality representation during inspections
• Establish and maintain a supplier quality management program, including qualification, monitoring, audits, and performance reviews
• Promote a prevention-based quality culture through training, risk management, and continuous improvement initiatives

Job description

Lead Quality Operations and the Quality Management System (QMS) for a San Diego manufacturing site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership across Quality Assurance and Quality Control, drives continuous improvement and risk management, and partners closely with site leadership to strengthen product quality, operational performance, and customer satisfaction. Reports to the Quality Director and works cross-functionally with Operations, Production, Engineering, Customer Service, and Sales.

Responsibilities

• Own the QMS and Quality Operations, ensuring compliance with regulatory, customer, and business requirements
• Provide leadership, coaching, talent development, and performance management for QA/QC teams
• Develop and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality
• Establish quality objectives and KPIs aligned with business goals
• Lead quality risk management across products, processes, suppliers, and quality systems throughout the product lifecycle
• Ensure effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls
• Lead Management Reviews and report quality performance, compliance, risks, and improvement initiatives to executive leadership
• Direct internal, supplier, customer, certification, and regulatory audit programs, ensuring timely closure of findings
• Ensure audit readiness and lead Quality representation during inspections
• Establish and maintain a supplier quality management program, including qualification, monitoring, audits, and performance reviews
• Promote a prevention-based quality culture through training, risk management, and continuous improvement initiatives

Requirements

• Bachelor's degree in Engineering, Manufacturing, Quality, or a related field
• 5–7 years of experience in Engineering and/or Quality, preferably in medical device
• 3+ years in a supervisory or management role
• Experience with quality risk management principles in a regulated manufacturing environment
• Expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes
• Track record leading teams and driving continuous improvement in quality, compliance, and business performance
• Proficient in MS 365 applications
• Experience with ERP/MRP systems, electronic QMS (eQMS), and data analytics/reporting tools
• Comfortable working in both office and manufacturing environments