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 103,000 colleagues serve people in more than 160 countries.
Quality Systems Engineer II
- Support all Business Unit initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Perform and assure timely follow-up activities in support of key quality and compliance metric/data goals and policy/procedural requirements
- Assists with Quality System activities, projects, and initiate document changes
- Supports the coordination of the external audits/inspection preparation and provides back room support as required
- Track and follows up on audit finding responses to ensure timely closure of audit observations
- Assist in the initiation, processing and completion of Internal/External Audit responses and records in the EPIQ electronic system.
- Supports investigating and resolving system nonconformities (defined during internal and/or external audits)
- Supports in data and metric analysis. Analyze quality data and generate metric reports and presentations to support Management Reviews.
- Complete trend analysis of data as appropriate to ensure proper actions can be determined or assessed
- Supports the CAPA System elements for the site.
- Helps with the resolution of problems including identifying causes to prevent re-occurrence
- Performs related functions and responsibilities as assigned.
- Complies with U.S. Food and Drug Administration (FDA) regulations, all other applicable regulatory requirements (including non-US regulations, company policies, operating procedures, processes, and task assignments.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Travel up to 5% of the time both domestically and internationally by any means necessary to support organizational goals
Engineering or Technical Field or equivalent combination of education and work experience
Required - Two to Five Years’ Experience:
- Relevant Quality Assurance/Quality Systems/ Quality Engineering experience and demonstrated use of quality tools/methodologies.
- Working knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.
- Technical report writing skills, strong organizational skills and follow-up skills, as well as attention to detail.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Knowledge of EUMDR and MDSAP regulations
- Solid communication and interpersonal skills.
- Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
- Project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- ASQ, CQE or CQA
- Certification as a quality engineer (e.g. CQE) or Quality Auditor (CQA)Certification granted through the American Society of Quality (ASQ)
- Medical Device Quality Experience