Quality Management System & Control Administrator in Clearwater, Florida at Mercury Medical

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 13485-certified 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.