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.