Quality Engineer I

Abbott Laboratories - Saint Paul, MN (30+ days ago)4.1

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.

Major responsibilities include:
Conduct and document complaint investigations on returned product per department complaint handling procedures
Utilize risk management documentation to assess risk of as-reported and as-found product events
Analyze complaint data for statistical trends, communicate and recommend corrective action to product development, quality engineering, and manufacturing engineering to drive improvement
Identify and implement process improvements to returned product flow and lab procedures
Develop, implement, and manage troubleshooting guides for complaint investigations
Review and approve product investigations, and closure of complaint files in accordance with company and regulatory requirements
Analyze product failures, perform circuit analysis, and conduct component level failure analysis

Job Knowledge / Experience Required:
Bachelor’s Degree in Engineering (Electrical focus desired), applicable Technical Field or documented and proven equivalent experience
1-2 years electrical/electronic experience
Risk management experience
Computer knowledge is essential (especially Microsoft Office Suite)
Demonstrated ability to understand and comply with applicable industry regulations and follows company operating procedures, policies, and rules is essential
Ability to use test equipment such as oscilloscopes, volt meters, & macroscopes
Strong analytical and statistics skills
Solid communication and interpersonal skills

Other Desirable Qualifications:
Working knowledge of FDA, GMP, ISO 13485, and/or ISO 14971
Participate in cross-functional teams with minimal supervision
Experience in a regulated industry is desirable
Data analysis knowledge is desirable