Abbott Quality Manager (Development) in Temecula, California
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 103,000 colleagues serve people in more than 160 countries.
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 Manager (Development). 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.
WHAT YOU’LL DO
Provide Quality Engineering leadership in direct support of medical device development, including:
Management and development of Quality Engineers and Technicians
Manage the activities of the Post-Production Quality Engineering team
Provide 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
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.
Ability to travel internationally to support international manufacturing sites. Ability to travel approximately 15-25%, including internationally.
Industry certification or advanced degree preferred.
Six Sigma Black Belt preferred.
ASQ Certified Quality Engineer strongly preferred.
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
Production areas that are clean, well-lit and temperature-controlled
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 at http://www.abbottbenefits.com/pages/candidate.aspx
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 at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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 email@example.com