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 113,000 colleagues serve people in more than 160 countries.
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
**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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-stude...) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree...) 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.
This position works out of our **Sylmar, CA** location in the **Cardiac Rhythm Management** division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
**Development Quality Engineer II** 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 Work On**
+ 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
+ Bachelors Degree (± 16 years) Engineering or Technical Field OR an equivalent combination of education and work experience
+ Masters Degree (± 18 years) Preferred
+ Minimum 2 years
+ 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(if required).
Apply Now (https://www.jobs.abbott/us/en)
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The salary for this role is between $65,200 – $130,400
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 firstname.lastname@example.org