Quality Manager

Abbott • Temecula, CA

1d • Onsite

About The Position

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.

Requirements

• Bachelors Degree in related field or an equivalent combination of education and work experience
• Minimum 5 years in quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment
• Demonstrated and impactful experience in design control, test method validation, risk management and related industry product standards.
• Demonstrated and impactful strong project management and people leadership skills required.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Demonstrated performance and results design related nonconformance management and reduction, value improvement, risk reduction, and cost containment.

Nice To Haves

• Industry certification or advanced degree preferred.
• Six Sigma Black Belt preferred.
• ASQ Certified Quality Engineer strongly preferred.

Responsibilities

• 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.

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
• Number of Employees: 5,001-10,000 employees