Quality Manager

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 is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Description

Job Title

Quality Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career of which you dream.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

THE OPPORTUNITY

Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role.

This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

Abbott Vascular provides innovative, minimally invasive and cost‑effective products for treatment of vascular disease. Our extensive portfolio includes drug‑eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

WHAT YOU’LL DO

• Provide Quality Engineering leadership in direct support of medical device development, including:
• Management and/or influence and development of Quality Engineers and Technicians
• Provide Design Control Quality Engineering Body of Knowledge guidance and leadership to department and organization
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement critical parameter for design control and related systems throughout the product lines
• Provide influential peer leadership with international partner site to drive proactive quality improvements
• Identify Quality Initiatives and lead cross-functional teams to complete them
• Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Oversee the Nonconformance and Real‑time data management portions of the quality System
• Be an effective member of the cross‑departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization
• Manage the activities of the Post‑Production Quality Engineering team.
• Support ATE at all stages of development process and ensure its compliance to FDA and other agencies.
• Assist R&D in validation of NPS tools.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required Experience:

• Bachelor’s Degree in related field or an equivalent combination of education and work experience
• Minimum 5 years in quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment
• Demonstrated and impactful experience in design control, test method validation, risk management and related industry product standards.
• Demonstrated and impactful strong project management and people leadership skills required.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
• Ability to work effectively within a team in a fast‑paced changing environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multi‑tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow‑up skills and ability to hold others accountable
• Demonstrated performance and results design related nonconformance management and reduction, value improvement, risk reduction, and cost containment
• Ability to travel 10-20% to support manufacturing sites, including international travel

Preferred Experience:

• Industry certification or advanced degree preferred
• Six Sigma Black Belt preferred
• ASQ Certified Quality Engineer strongly preferred

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com.

The base pay for this position is $99,300.00 – $198,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

AVD Vascular

LOCATION:

United States > Temecula : Building E - TE

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf