Quality Analyst SR

HCR0003319
Title:Quality Analyst SR
Location: Raleigh NC
Pay : $35./HR on W2

The role is set up on a 3 month contract that can be extended

HYBRID - Monday to Friday, 8am-5pm (this role now requires 3 days onsite in the office, and 2 days remote)

Job Description:

1. Requires 12-15 years of Quality Assurance experience, including experience managing and implementing a Quality Management System. The position of QMS Specialist is responsible for providing expertise and guidance for R&D Quality activities that support the company's Quality Management Systems (QMS).

2. This position is responsible for both conducting and managing Document Control responsibilities in addition to independently performing vendor qualification activities within the QMS. Organization and communication skills are essential to this role.

3. Activities include but are not limited to procedural document management, vendor qualification, audit/inspection support, and special project management to assure QMS alignment and compliance. This position works with minimal supervision, requires a very high degree of interaction with other company employees and resolves more complex issues requiring evaluation of identifiable factors. Standard operating procedures provide guidance in performing the activities required.

Education
Bachelors Degree Minimum

Kindly share resume with answers:
Q1:  How many years of experience do you have in Quality Assurance within the Medical Device industry?
Q2: Do you have hands-on experience managing and implementing a Quality Management System (QMS)?
Q3: Have you worked with FDA 21 CFR Part 820 requirements?