Overview
Software QA Engineer (Remote US) Jobs in Jersey City, NJ at Neptune Retail Solutions
DUTIES AND RESPONSIBILITIES
Lead responsible for ensuring that assessment and routing of Post-Market Surveillance complaint intake records to the company eQMS is performed correctly and 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 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 and maintaining various QA and Operational control charts – to be defined by Quality Engineering and Operations – using Excel functions such as Pivot Tables and V-Lookup formulae.
Monitor and coordinate timely calibration and preventive maintenance services 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 document delivery.
Support Operations department with various ERP administrative duties such as performing eRequisitions.
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 an Associate’s degree is required; Bachelor’s degree (no particular specialty sought) is a plus.
Experience in using Epicor as the company ERP is a plus, but not required.
Experience in using Greenlight Guru as the company eQMS is a plus, but not required.
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.
BENEFITS
Excellent compensation package includes salary, medical/dental insurance, 401K plan, FSA plan, paid holidays, paid sick days, paid vacation and more! Full time at our Bohemia location. Hours are Monday thru Friday 9 am to 5 pm. (35 hour work week)!!
Job Type: Full-time
Pay: $50,000.00 – $55,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Employee discount
Flexible spending account
Health insurance
Life insurance
Paid time off
Parental leave
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: In person
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Title: Software QA Engineer (Remote US)
Company: Neptune Retail Solutions
Location: Jersey City, NJ
