Manager Quality

4 weeks ago

Temecula, United States Abbott Laboratories Full time

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 114,000 colleagues serve people in more than 160 countries.

**About Abbott**

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Abbott Vascular provides innovative, mínimally 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

Our location in Temecula, CA, currently has an opportunity for an Manager, Quality.

**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.

Main Responsibilities:

- 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.
- 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.
- Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
- 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 YOU’LL BRING**:
Bachelor's degree (preferably Engineering) and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.

Medical devices experience is preferred.

Manufacturing background and supervision experience.

Influence/Leadership:

- 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

Planning/Organization:

- 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;
- Generally 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 indi

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