Quality Engineer II at Abbott Pediatrics

Minnetonka, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

31 May, 26

Salary

122700.0

Posted On

02 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Control Systems, CAPA Systems, Problem-Solving Methodologies, Experiment Design, Process Optimization, Process Monitoring, Six Sigma, Lean Manufacturing, Non-conformance Resolution, Risk Analysis, QMS Compliance, FDA Regulations, GMP Compliance, ISO 13485, ISO 14971, Communication

Industry

Hospitals and Health Care

Description

Quality Engineer II 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 Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer II, you’ll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. What You’ll Work On Identify and implement effective process control systems to support the qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Work with cross functional teams to design and conduct experiments for process optimization and/or improvement. Appropriately document experiment plans and results, including protocol writing and reports Lead process control and monitoring of CTQ parameters and specifications. Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) Lead the investigation, resolution and prevention of product and process non-conformances. Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) Lead in the completion and maintenance of risk analysis. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees. Required Qualifications Bachelor’s Degree in engineering or Technical Field or an equivalent combination of education and work experience 2-5 years Engineering experience and demonstrated use of quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 Ability to work in a highly matrixed and geographically diverse business environment Ability to work within a team and as an individual contributor in a fast-paced, changing environment Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Multitasks, prioritizes, and meets deadlines in timely manner Strong organizational and follow-up skills, as well as attention to detail Preferred Qualifications Prior medical device experience preferred. CAPA owner or a key cross-functional team member leading a CAPA. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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 $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

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Responsibilities

The Quality Engineer II will support the sustainability of commercially released products, ensuring manufacturing processes meet production schedules while enhancing productivity and quality, and assuring all products conform to established compliance requirements within the Quality Management System. Key tasks include identifying and implementing process control systems, leading CAPA implementations, applying problem-solving methodologies, and leading product/process improvement initiatives.