Quality Manager

BioTalent Ltd; San Diego (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

BioTalent Ltd is seeking a senior quality leadership professional to Lead Quality Operations and the QMS at our San Diego manufacturing site. You will drive compliance with regulatory, customer, and business requirements while partnering with site leadership to improve product quality and customer satisfaction.

You will oversee QA/QC teams, CAPA, risk management, audits, and continuous improvement initiatives, reporting to the Quality Director.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Quality, or related field.
• 5–7 years in Engineering/Quality, preferably in medical device.
• 3+ years in supervisory or management role.
• Experience with quality risk management in regulated manufacturing.
• Expertise in CAPA, nonconformance, root cause analysis, and CAPA processes.

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

Skills

Quality leadership

CAPA & NCM

Risk management

QMS knowledge

Data analytics

Regulated manufacturing

Supplier quality

Education

Bachelor's degree in Engineering, Manufacturing, Quality

Tools

MS 365

ERP/MRP systems

eQMS

Job description

Position Overview

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, including occasional lifting up to 25 lbs