Quality Management System & Control Administrator

Quality Management System & Control Administrator Mercury Medical - 3.8 Clearwater, FL Job Details Full-time 21 hours ago Qualifications Record keeping Document review (document control) Technical documentation Training FDA regulations Full Job Description

RESPONSIBILITIES

Document Control and Records Management eQMS Administrator (Future State) Change Control and Engineering Change Order (ECO) Management Audit and Compliance Support General and Administrative as assigned by Director of

QA/RA EDUCATION

Associate's degree required; Bachelor's degree in related field (Life Sciences, Business, Quality, or similar) preferred. Equivalent combination of education and directly relevant experience will be considered.

EXPERIENCE

Minimum 3 5 years of document control experience in a regulated industry, with medical device experience strongly preferred. Demonstrated experience administering or working within an eQMS platform (e.g., MasterControl, Greenlight Guru, Veeva, ETQ, or similar); system administrator a plus. Working knowledge of

FDA 21 CFR

Part 820/QMSR, ISO 13485:2016, EU MDR 2017/745, and MDSAP document and records control requirements. Familiarity with Good Documentation Practices (GDP) and the ability to apply and train others in a regulated manufacturing environment. Experience maintaining or contributing to technical documentation packages including

DEVICE HISTORY FILES

(DHF), DEVICE

MASTER RECORDS

(DMR), and

TECHNICAL FILES.

KNOWLEDGE, SKILLS and

ABILITIES

Strong working knowledge of document control principles, GDP, revision control, and records retention requirements in a regulated environment. HIGH attention to detail with a low tolerance for ambiguity in controlled documentation. Proficient in Microsoft Office Suite.

PREFERRED QUALIFICATIONS

Experience in a 510(k)cleared, CE Marked, or ISO 13485certified medical device manufacturing environment. Familiarity with 21 CFR Part 11 electronic records and signature requirements. Experience participating in eQMS implementation or migration projects. MDSAP audit experience as a document control or quality systems resource. About Mercury Medical Mercury Medical is dedicated to bringing innovative medical devices to the market with over 60 years of Medical Device Sales and Development. Mercury Medical is Dedicated to delivering clinically differentiated critical care technology that saves lives throughout the world. Known for innovative products, we design, manufacture and distribute our own leading-edge airway management product line worldwide and represent cutting edge technology from other manufacturers exclusively.