Senior Quality Engineer

Abbott • Westfield, IN

19h • $78,000 - $156,000 • Onsite

About The Position

Senior Quality Engineer 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. The Opportunity This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Senior Quality Engineer will be responsible for implementing and maintaining an effective Quality System.

Requirements

• Bachelor’s degree preferably in science, engineering or a closely related discipline or an equivalent combination of education and work experience.
• 5+ years of 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 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.

Nice To Haves

• Masters Degree preferably in science, engineering or a closely related discipline.

Responsibilities

• Responsible for implementing and maintaining an effective Quality System.
• Independently lead groups and projects to resolve complex issues.
• analyze complex problems and identify their impact.
• establish probabilities.
• draw conclusions reflecting broad business needs.
• ensure compliance.
• Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Work may require collaboration with other Division sites and/or other Abbott divisions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Travel up to 10% of the time both domestically and internationally by any means necessary to support organizational goals
• Understand and comply with applicable EHS policies, procedures and guidelines.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level