Manager Quality Assurance

Abbott Laboratories • Temecula, CA

2d • $99,300 - $198,700 • Onsite

About The Position

This position provides leadership and guidance for the department, has responsibility for recruiting, developing and retaining talented employees, supports company goals and objectives, and communicates key information to staff members and senior management. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Requirements

• Minimum of a Bachelor's degree An equivalent combination of education and work experience
• Minimum of 6 years of experience within the healthcare, medical device, or biotechnology industry.
• Medical Device experience highly preferred

Responsibilities

• 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 lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, MedDev, DOH regulations etc).
• Notifies appropriate personnel for possible litigation and aids and responds to requests for information related to litigation concerns.
• Monitors complete complaint handling process from first contact through closure of file and notifies appropriate personnel of issues that prevent a smooth flow.
• Maintains personnel records and where appropriate develops work schedules for departments customer complaint hotline to ensure no customers are transferred to v-mail during business hours.
• Develop strategies for regulatory reporting of medical devices.
• Coordinate MDR, Vig, MHLW, reporting activities for a variety of device regulatory requirements including: US post market studies, IDE exemptions, international regulatory reporting and annual summaries.
• Develop and deliver presentations to global regulatory agencies and other business units.
• Coordinate Division comments on proposed regulations.
• Represent Division in industry feedback for changes in regulatory law.
• Serve as internal consultant on regulatory issues such as regulatory processes, interpretation of regulatory laws or review of proposed regulatory position changes.
• Participate in department systems development initiatives, which may include complaint database development.
• 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.
• 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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager