Supplier Development Quality Engineer Lead

Overview

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.
• 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 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.

The Opportunity

This position works out of our Pleasanton, CA location in under the Medical Device, Heart Failure Division.

As the Supplier Development Quality Engineer Lead you will be responsible for implementing and maintaining an effective Quality System, planning, executing, and documenting audits of external suppliers to ensure compliance with FDA, ISO 13485, and internal quality standards. This role drives supplier performance improvements and collaborates cross-functionally to uphold regulatory and operational excellence.

What You’ll Work On

• Work cross-functionally to lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, and qualifications.
• Provide training and mentorship to internal stakeholders on supplier audit processes and compliance expectations.
• Independently lead cross-functional teams to analyze and resolve complex issues with broad operational impact.
• Draw conclusions reflecting broad business needs and ensure compliance.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Work may require collaboration with other Division sites and/or other Abbott divisions.
• Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.
• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
• Drives functional performance that ensures cross-functional standards and expectations are met.

Required Qualifications

• Bachelors Degree Preferably in science, engineering or a closely related discipline or an equivalent combination of education and work experience
• 5 years of relevant experience
• Relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.
• Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11).
• Knowledge of medical device standards, ISO 13485.
• Knowledge of quality management techniques and the application and principles of quality engineering.
• Strong 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.
• Understanding of statistics.
• 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 and 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.
• Ability or aptitude to lead without direct authority.
• Ability to travel approximately 40% annually

Preferred Qualifications

• Masters Degree
• ASQ, CSQP, CQE, CQA or other certifications

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Learn more about our health and wellness benefits at Abbott benefits (no links included).

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at Abbott, on Facebook, and on Twitter. The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.