Quality Engineer

2 months ago

Temecula, United States Abbott Laboratories Full time

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. Youâll 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 bachelorâs 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.

THIS IS AN ONSITE DAILY ROLE.

WHAT YOU'LL DO:

Primary Job Function

Identify, analyze, investigate, monitor, and document patterns and trends in post-marketing surveillance data as part of the CAPA system.

Analyze and investigate product complaints from the field as part of post-market surveillance requirements.

Communicate and educate management, R&D, marketing, sales organization, and other departments, as well as external customers about product performance. 

Ensure that information and insight gained from the investigations and corrective actions are fed back to the R&D and marketing organizations 

as part of the risk management and design input systems.  Develop Post Market Surveillance Plans and provide engineering  support

 for complaint investigation readiness of new products.

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

1.Analyzes customer complaints, events, and other post-marketing surveillance data by examining the data for patterns and trends and  investigating when necessary.;

2. Investigates customer complaints related to product quality or patient safety.;

3. Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.;

4. Documents trend action by updating the trend report at appropriate  levels and by performing a Health Risk Analysis.;

5. Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for 

performance information either directly or through the sales organization.;

6. Provides input for process improvement and helps develops tactical approaches to implement team strategies.;

7. Develop test plans, procedures, and justification papers and provide engineering support for new product complaint readiness.

(Supervision Received)

Works under only general direction. Independently determines and develops approaches to solutions. Work is reviewed upon completion for adequacy in meeting objectives.;

(Supervision Provided)

May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Position Accountability / Scope

(Influence/Leadership)

Establishes and cultivates an extensive network of support to facilitate the completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.

May lead a project team.  Participates in determining goals and objectives for projects.  Influences middle management on technical or business solutions.  May interact with vendors.;

(Planning/Organization) 

Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments.;

(Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

EDUCATION AND EXPERIENCE YOUâLL BRING:

Minimum Education

Bachelor's degree(Engineering/Life Sciences) (Electrical Engineering preferred) plus 2-5+ years of related work experience with a strong

understanding of the specified functional area, or an equivalent combination

of education and work experience. Advanced degree preferred.

Minimum Experience / Training Required

(Technical/Business Knowledge (Job Skills)) Wide application of technical principles, practices, and procedures. Strong understanding of the business unit function and cross-group dependencies/relationships.

Will perform this job in a quality system environment.  

Failure to adequately perform tasks can result in noncompliance with 

governmental regulations.;

* CQE Certification a plus

* Medical Devices experience preferred

* CAPA experience

* Experience working with Quality Systems

* Data Analysis experience

* Risk Management experience

(Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. 

 Exercises judgment within generally defined practices and policies in selecting

methods and techniques for obtaining solutions.

Has a sound knowledge of various technical alternatives

and their impact.

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
  • 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 â $114,700.00. In specific locations, the pay range may vary from the range posted.

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