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 ins... more details
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.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of .
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- 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.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
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 Engineer.
Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
WHAT YOU’LL DO
- 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Minimum Education:
Bachelor's degree AND 2-5+ years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education and work experience.
Minimum Experience / Training Required:
- Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
- Experience working in a broader enterprise/cross-division business unit model preferred.
- 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.
Experience Required:
- RM/FMEAs
- Statistics
- Medical Devices or Pharmaceutical experience
- Quality Engineering
Experience preferred:
- ISO
- FDA Regulations
- Regulatory
- ASQ
- Manufacturing
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
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, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$57,300.00 – $114,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
AVD Vascular
LOCATION:
United States > Temecula : Building E - TE
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
