Overall Responsibilities:
Responsible for the coordination of all aspects of product complaint investigation in accordance to CFR 21 Part 820 and 803.
Duties & Other Responsibilities:
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Review all complaint investigations to ensure that investigations adequate and consistent.
Communication of complaint investigations to internal and external customers.
Participate in MDR team meetings and play an active role in determining investigation requirements for individual complaints.
Triage incoming complaints and document requirements for investigation.
Review complaint histories and identify trends.
Perform product evaluations as necessary.
Other duties as assigned.
Professional Experience & Educational Requirements :
Background in quality or regulatory compliance in the medical device industry preferred.
Must have a background in manufacturing engineering or product development in the medical device industry.
Must be familiar with Word, Excel, Access and J.D. Edwards.
Must have excellent written and oral communication skills.
Excellent organizational skills.
Attention to details and follow-up
Prior experience conducting or reviewing product complaint investigations preferred.
B. S. Degree in Engineering, preferably Mechanical or Biomedical
Synthes - 12 months ago
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