Abbott · 15 hours ago
Quality Manager
Temecula, CA
Full-time
Onsite
Mid, Senior Level
$99K/yr - $199K/yr
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Manager will be responsible for developing, establishing, and maintaining quality assurance programs and ensuring that products conform to established standards and regulations.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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
Qualification
Required
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
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 10-20% to support manufacturing sites, including international travel
Preferred
Industry certification or advanced degree preferred
Six Sigma Black Belt preferred
ASQ Certified Quality Engineer strongly preferred
Benefits
Career development with an international company where you can grow the career of which you dream.
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.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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