Abbott Quality Engineer I - Post Market Investigations in Atlanta, Georgia
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 a Quality Engineer I to be responsible for post market investigations and improvement projects associated with product quality.
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:
A Quality Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
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
Job Knowledge / Experience
Bachelor’s Degree in Engineering, applicable Technical Field or documented and proven equivalent experience
1-2 years quality engineering, software or 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
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
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 email@example.com