Quality Manager

Quality Manager (Development)

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.

Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. 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.

What You'll Do :

• Provide Quality Engineering leadership in direct support of medical device development, including :
• Management and / or influence and development of Quality Engineers and Technicians
• Provide Design Control Quality Engineering Body of Knowledge guidance and leadership to department and organization
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement critical parameter for design control and related systems throughout the product lines
• Provide influential peer leadership with international partner site to drive proactive quality improvements
• Identify Quality Initiatives and lead cross-functional teams to complete them
• Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Oversee the Nonconformance and Real-time data management portions of the quality System
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization
• Manage the activities of the Post-Production Quality Engineering team.
• Support ATE at all stages of development process and ensure its compliance to FDA and other agencies.
• Assist R&D in validation of NPS tools.

Education and Experience You'll Bring :

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. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com.