Abbott · 16 hours ago
Quality Engineer
Temecula, CA
Full-time
Onsite
Entry, Mid Level
$61K/yr - $123K/yr
2+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Quality Engineer in their Vascular Division to ensure that new or modified products conform to quality standards and to maintain compliance with the quality system while collaborating with cross-functional teams.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Execute and support on-time completion of Design Control Deliverables
Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Lead or support Risk Management activities from product Concept through Commercialization
Support design test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
Support internal & external audit responses
Support product re-certifications
Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Support execution of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Bachelor's degree in related field
2-5+ years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education and work experience
Medical Devices or other highly regulated industry experience
Understanding of ISO, ASQ, RM/FMEAs and FDA Regulations
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 10%, including internationally
Preferred
Experience working in a broader enterprise/cross-division business unit model preferred
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
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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