Abbott Quality Systems Engineer I in Plymouth, Minnesota

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

We are seeking an experienced, high caliber Engineer I, Quality Engineering to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within quality system/services support.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

  • Provides Quality System Body of Knowledge support to organization.

  • Investigates, and resolves system nonconformance’s (defined during internal and/or external audits.

  • Develops QS related reports (i.e. Quality plans, reports, process documentation) to support business activities

  • Provides Quality System Body of Knowledge support to organization.

  • Investigates, and resolves system nonconformance’s (defined during internal and/or external audits.

  • Develops QS related reports (i.e. Quality plans, reports, process documentation) to support business activities

  • Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and leads activities to implement improvements.

  • As appropriate, utilizes quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in quality system compliance, device, and process.

  • Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.

  • As appropriate, support teams in quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)

  • As appropriate, support completion and maintenance of risk analysis, as related to quality systems.

  • Support of core Quality System activities (e.g. Management Review preparation, External Standards, Org Responsibility, Quality Manual) to meet process requirements

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Other Duties:

  • Support all Abbott initiatives as identified by management and in support of Quality Management Systems (QMS) 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, customers, contractors, and vendors.

  • Performs other related duties and responsibilities, on occasion, as assigned.

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

  • BS degree in Engineering or Technical Field or equivalent experience;

  • 0-2 years’ experience

  • Engineering experience preferred

  • Knowledge of Quality tools/methodologies

  • Solid communication and interpersonal skills

  • Advanced computer skills, including statistical/data analysis and report writing skills

  • 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.

  • Ability to leverage and/or engage others to accomplish projects.

  • 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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com