Manager QA Reliability

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.

     

JOB DESCRIPTION:

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 Manager QA Reliability.

This is an onsite daily position

MAIN PURPOSE OF THE ROLE

Incumbent serves as process owner for Complaint Handling Investigation process.  They are the subject matter expert and representative for the Formally Designated Unit (FDU) and serve as a contact for the complaint investigation process during audits, inspections and assessments by regulatory agencies, globally. Works closely with manufacturing sites to identify potential product deficiencies and works with team to timely open exceptions for further investigation of these issues.  In addition, provides support to the Commercial Teams when inquiries are made about product experiences, including meeting with physicians and hospital staff. Additionally this position is responsible for personnel development and assessing performance. Provides direct and indirect supervision to professional, direct or indirect labor staff to ensure that complaints are handled in accordance with global regulations and internal procedures. Ensures that compliance is maintained and that employees are trained and following the required divisional and Abbott policies and procedures. Interacts with division's Senior management in the area of complaints handling and issues affecting product performance. Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues.

WHAT YOU’LL DO

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Identifies and recruits staffing / resources to support complaint handling activities and on-market support for all Vascular products.
• Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization.
• Ensures complaints are investigated in a meaningful way to identify product deficiencies.
• Champions and actively participates in development / improvements of complaint handling processes and procedures.
• Work effectively with R&D, as well as other internal and external organizations as needed, to coordinate and facilitate improvements in AV products based on feedback received in complaint handling processes.
• Works closely with PPG Data Management, Supplier QA and Operations teams to ensure that exception reports and corrective and preventive actions are conducted as necessary for complaint issues.
• Facilitate meetings and discussions across multiple organizations as required to improve/enhance complaint handling processes.
• Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the
• data.
• Responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system.
• The incumbent also has a high level of interaction with FDA / Notified body during inspections.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor's Degree in a scientific or technical discipline
• Minimum 8 years - Quality experience in medical devices or pharmaceutical regulated environment
• Minimum 3 years -  Managing/leading organizations
• Minimum 2 years - Complaint Handling Experience
• Substantial knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971
• Must have demonstrated solid knowledge and experience in discipline. Demonstrated leadership competencies.
• Considered a Subject Matter Expert.
• Demonstrated ability to lead cross-functional projects.
• Flexibility, strong problem solving skills, excellent written and oral communication skills, solid organizational ability, negotiations skills with ability to drive cross functional teams.
• Emerging leader that demonstrates strong leadership competencies

Preferred:

• Master's Degree in a scientific or technical discipline