Manager, Quality Assurance

Abbott; Temecula (CA); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health benefits

Tuition reimbursement

Retirement plan with employer matching

Education subsidies

Job summary

Abbott’s Temecula site seeks a Quality Assurance Manager to lead the QA engineering team and ensure high-quality manufacturing. This onsite role focuses on directing projects, ensuring regulatory compliance, and developing staff through training and performance reviews.

You will coordinate with customers and internal stakeholders, implement quality system improvements, and monitor budgets to support the unit’s goals in a regulated environment.

Qualifications

• Bachelor's degree in Engineering and 9+ years of related work experience.
• Advanced degree preferred.
• Proven leadership to assign, train and develop staff.
• Experience budgeting and monitoring costs.
• Ensures compliance with FDA/BSI/EEO regulations.

Responsibilities

• Leads the team of Quality engineers to support manufacturing.
• Directs projects to ensure high quality product and regulatory compliance.
• Develops training and performance reviews for direct reports.
• Interacts with internal and external customers; communicates procedures.
• Implements improvements to Quality Systems and tools.

Skills

Leadership

Regulatory compliance

Staffing planning

Performance management

Customer interaction

Process improvement

Education

Bachelor's degree in Engineering

Advanced degree

Tools

Quality System tools

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 122,000 colleagues serve people in more than 160 countries.

Job Description

Job Title: Quality Assurance 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 Manager, Quality Assurance. THIS IS AN ONSITE ROLE.

What You’ll Do

Leads the team of Quality engineers to support manufacturing. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translates department goals into individual objectives and KRAs.
• Identifies, develops and implements processes to improve department performance.
• Monitors departmental activities and records to ensure compliance independent action through critical decision making.
• Provides supplier development support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Education and Experience

• Bachelor's degree (preferably Engineering) and 9+ years of related work experience or an equivalent combination of education and work experience.
• Advanced degree preferred.
• Promotes the attainment of group goals by selecting, motivating, and training capable staff.
• Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
• Schedules human and material resources within a group or section in conjunction with near‑term plans to ensure their availability.
• Carries out operations within an established budget.

Decision Making / Impact

Assignments are expressed in the form of tasks and objectives; Makes day‑to‑day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

Technical / Business Knowledge (Job Skills)

Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Cognitive Skills

• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.

Benefits

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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Equal Opportunity and EEO

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

Compensation

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 Details

Job Family: Operations Quality

DIVISION: AVD Vascular

LOCATION: United States > Temecula : Building E - TE

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % 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)

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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