Quality Assurance Engineer
Job in
Baltimore, Anne Arundel County, Maryland, 21276, USA
Listed on 2025-12-20
Listing for:
Lumicity
Full Time
position Listed on 2025-12-20
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, QA Specialist / Manager -
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below
Responsibilities
- Support failure analysis for medical and field return complaints, utilizing testing, standard lab processes, and/or data analysis.
- Assist with internal and external audits related to customer complaint documentation and handling activities.
- Stay informed on the data and information required for technical complaints to maintain compliance with applicable regulations and directives.
- BS in Engineering or a related Scientific field is preferred.
- A minimum of 5 years’ experience in the life sciences industry, with 1-2 years of experience in medical device complaint documentation and processing strongly preferred.
- Familiarity with 21 CFR 820, 21 CFR 803, ISO 13485, and ISO 14971
- Experience working in a GMP and/or ISO-regulated environment is an advantage.
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