Sr. Quality Engineer

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 your 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.
• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

We are currently looking for a Senior Quality Engineer.

THIS POSITION IS ON-SITE DAILY.

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

CAN BE BASED IN Temecula, CA (Preferred), Santa Clara, CA or Westford, MA.

WHAT YOU'LL DO:

Perform Abbott Vascular data management quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. Work closely with R&D, Equipment Engineering, Quality Engineering and BTS on risk identification and mitigation activities. Facilitate cross functional team collaboration to achieve data management goals. 

MAIN RESPONSIBILITIES

• Support AV data management project plan and perform assessment and mitigation with cross functional team. Develop and manage data management training program including training material and training audience. Track and report data management metrics.
• Provide support to internal and external audits. Manage data management audit findings and CAPAs.
• Continuously improve data management process to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations. manages multiple often concurrent projects.
• Lead complex technical projects with multiple inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.
• Lead and/or participate on cross-functional teams to support organizational goals.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters. may interface with external firms or agencies.
• Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Assists with evaluating project costs.
• Identifies, develops and implements processes to improve department performance.
• Directs Quality personnel to support quality system initiatives based on coordination with management, project leaders, & design engineers.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

QUALIFICATIONS

Experience/Background

Minimum Education

Bachelor's degree (Engineering/Life Sciences) AND 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work 

experience. Advanced degree preferred.

Experience

Minimum 6+ years.  Requires 6-7 years of quality experience to develop the competence to meet the skills and responsibilities of the position.

• Strong technical knowledge and application of concepts, practices and procedures.
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills.
• Critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize.
• Strong organizational and project management skills.
• Demonstrated competency with financial systems and in fiscal controls.
• Ability to quickly gain knowledge, understanding or skills and is willing to learn.

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

$75,300.00 – $150,700.00

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:United States > Massachusetts > Westford : 4 Robbins Road, United States > Santa Clara : Building A - SC

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