Quality Leader, Medical Device Development

Abbott; Temecula (CA); On-site; USD 99,300 - 198,700; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

FreeU education benefit

Retirement plan

Career development

Job summary

Abbott, located in Temecula, CA, is seeking a Quality Manager (Development) to lead quality engineering in medical device development. The role focuses on design control, risk management, and ensuring compliance with US FDA quality systems and ISO standards in a fast-paced environment.

The position requires 5+ years in quality within manufacturing support, strong leadership, and the ability to work across matrixed teams, with 10–20% travel and on-site presence in Temecula.

Qualifications

• Bachelor’s Degree in related field or equivalent education/experience.
• Minimum 5 years in quality with increasing responsibility in a manufacturing support environment.
• Experience in design control, test method validation, risk management and related industry product standards.
• Strong project management and people leadership skills.
• Experience in enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communications skills.
• Multi-tasking, prioritizes and meets deadlines with good organizational skills.
• Willingness to travel 10-20%, including international travel.

Responsibilities

• Provide Quality Engineering leadership in direct support of medical device development.
• Management and development of Quality Engineers and Technicians.
• Provide Design Control Quality Engineering guidance and leadership to department and organization.
• Ensure compliance to internal and external quality regulations (US 21 CFR 820, ISO 13485).
• Identify initiatives and lead cross-functional teams to improve quality and cost.
• Define and implement critical parameters for design control and related systems.
• Collaborate with international partner sites to drive quality improvements.
• Maintain quality metrics and drive continuous improvement across product lines.
• Oversee Post‑Production Quality Engineering activities and post-market considerations.
• Support ATE during development and ensure FDA compliance.

Skills

Quality leadership

Project management

Cross-functional collaboration

Six Sigma

Lean

Communication

Education

Bachelor’s degree

Job description

Abbott, located in Temecula, CA, is seeking a Quality Manager (Development) to lead quality engineering in medical device development. The role focuses on design control, risk management, and ensuring compliance with US FDA quality systems and ISO standards in a fast-paced environment.

The position requires 5+ years in quality within manufacturing support, strong leadership, and the ability to work across matrixed teams, with 10–20% travel and on-site presence in Temecula.