Job Opening For Quality Analyst At Westford, Ma

This is

Kartheek , a recruiter at Intellectt Inc. We have an opening for the below role with one of our medical device clients. Please go through the below JD and if you're interested, kindly share your updated resume to

********

or you can reach me directly at

+1 (551)-314-6451 .
Role: Quality Analyst

Location: Westford, MA

Looking For

QA role for compliance for quality.
Strong knowledge of the Medical device or Pharmacy industry.
Deep sound knowledge of regulatory requirements.
Support Internal/External Audits (50% of job activity will revolve around this); manufacturing site: cardio-vascular products. Product knowledge will be provided but he/she has to be a fast learner. Strong communication skills required as they will lead the complete external audit.
Conduct mock auditing at sites and be prepared for unplanned external audits.
Performing queries and analyzing reports. Must be good at math.
Good documentation skills; facilitate monthly busy meetings. Have good follow-up skills and gather all the information required to prepare the presentation to leadership.
Work closely with stakeholders (area owners) and bring up the potential risks in advance. Strong tactical skills needed and proactive people who can identify issues and bring them up to the leadership.
Hands-on experience with Quality, Regulatory, Design quality, or manufacturing background. This can be a dry task for some as it is more into documentation and auditing. So we need someone to be more energetic and active.
Non-Conformance/CAPA experience needed.
Must be an expert in Excel; running reports, manipulating data.
Combination of Regulatory and Engineering work.
Education And Experience

Bachelors: Regulatory affairs background.
Minimum 2 years experience in medical device/pharmacy.
Kartheek D
Recruiter
Intellectt Inc
********
Desk Number: ******** Ext: 149
Direct Number: ********
517 Route 1 South, Suite 1115 Iselin, NJ 08830

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