Lumicity
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.
Requirements
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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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.
Requirements
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.
#J-18808-Ljbffr