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, 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

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

WHAT YOU'LL DO:

Lead Abbott Vascular data management quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. Develop a risk-based data management program which meets regulatory requirements and aligns with industry leading information security practices. Work closely with R&D, Equipment Engineering, Quality Engineering and BTS on risk identification and mitigation activities using industry leading data management controls and tools sets. Collaborate with business units, application development teams, and third-party vendors to achieve program requirements while enabling the business. Facilitate cross functional team collaboration to achieve defined data management goals as well as meet technical requirements in support of detailed implementation plans for data management projects.

Main Responsibilities:

• Lead AV data management project plan and perform assessment and mitigation with cross functional team. Develop and manage data management training program including training material and training audience. Track and report data management metrics.
• Provide support to internal and external audits. Manage data management audit findings and CAPAs.
• Continuously improve data management process to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.
• 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.

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 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.

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

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

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.