Job Role: Quality Assurance Administrator
Duties and Responsibilities:
● Lead responsible for ensuring that assessment and routing of Material Review Board (MRB) records for nonconforming product is performed in accordance 21 CFR Part 820 and ISO 13485:2016 requirements.
● Lead responsible for generating and maintaining controlled Work Instructions of various MFG, ERP and electronic Quality Management System (eQMS) processes in the company eQMS replete with screenshots and full text directions of all related actions needed.
● Lead responsible for planning and execution of training records, training effectiveness verification records and related administrative routing duties in the company eQMS.
● Lead responsible for generating change orders in the company eQMS and maintaining Quality Assurance records via that process such as Certificate of Conformity (CoCs), Supplier/Purchasing records and Implementation plans.
● Monitor and coordinate timely calibration for company MFG equipment alongside the 3rd party vendors that travel on-site to perform and provide records of such service.
● Provide support for various regulatory-affairs sensitive customer interactions such as delivery to customers upon their request for Apostille, Certificate of Foreign Government, or other supervised FDA-related customer support.
● Support Operations department with ERP administrative duties such as performing eRequisitions or PO receipts.
Qualifications
● Minimum of 1 year experience in the Quality segment of a Medical Device or similarly regulated industry is required. (e.g. Aerospace, Automotive, Defense, Maritime, Nuclear Energy, Pharmaceuticals). Experience with 21 CFR Part 820 and/or ISO 13485:2016 is preferred but not required.
● Proficiency with Microsoft Office suite (Excel, Word, Powerpoint, Visio, etc) is required.
● Minimum of a high school diploma is required; Associates’ degree (no particular specialty sought) is preferred.
● Experience in using Epicor as the company ERP is preferred.
● Experience in using Greenlight Guru as the company eQMS is preferred.
● Cross-disciplinary team member. You are excited to work with software, mechanical, electrical, materials engineers or the clinicians who use our devices. You are comfortable communicating across teams.
● Resourceful, flexible and adaptable; you are a problem solver.
Working Conditions
There are no special working conditions (i.e. Cleanroom training or duties to be performed in a special environment) for this position. Attire for the role is business casual. This position will involve mostly sitting in an temperature/humidity-controlled factory floor with normal ambient lighting. This position is overtime eligible, although the frequency of such hours will vary widely based on the needs of our firm. The expected regular hours for the position are 7:30am EST – 4:00pm EST, Mondays through Fridays.
Physical Requirements
Exerting up to 20 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects with the assistance of other trained staff and select moving carts.
Substantial movements (motions) of the wrists, hands, and or/fingers. The worker is required to have close visual acuity to perform and activity such as:
· Transcribing
· Extensive viewing of a computer monitor posted at the inspector’s terminal
Pay: $25.00 - $26.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid jury duty
- Paid time off
- Parental leave
Work Location: In person
