Sr. Quality Systems Specialist

Treace•Ponte Vedra Beach, FL

17h

About The Position

POSITION SUMMARY: The Sr. Quality Systems Specialist (SQSS) is responsible for executing and supporting Quality System requirements in maintaining a compliant Quality System (ISO, FDA 21 CFR 820, etc.). Specifically, this role is responsible for creating procedures, assessing changes to procedures, auditing for compliance to procedures, leading CAPA system activities and recall activities, where required.

Requirements

Minimum high school diploma or equivalent required. An associate or bachelor’s degree in life sciences is strongly preferred.
A minimum of 5+ years’ experience in medical device or pharma quality systems role (e.g. Document Control, Quality Control, Post Market, etc.) is required

Nice To Haves

Prior root cause analysis training is preferred
Quality system auditor training or certification is preferred (ISO, other)

Responsibilities

Create and update quality system procedures, including performing biennial reviews to drive continuous improvement, align best practices, procedures and applicable regulations (FDA, ISO, etc.)
Administer, provide training and maintain SolidWorks Product Data Management (PDM) system and Arena Product Lifecycle Management (PLM) system
Modify Arena PLM configurations to meet evolving business processes, including the creation and management of configuration rules, BOM structure standards, and other system configurations
Administer, manage templates, and issue envelopes for signature within DocuSign platform
Administer and maintain quality system training (new hire, ongoing, annual, etc.) activities in eLMS (Absorb)
Supports standards review process by continuously monitoring regulations and guidance documents for required updates
Responsible for processing quality system, marketing collateral, and product documenting engineering change orders, reviewing for completeness and releasing controlled copies for use.
Performs internal quality system audits (for areas independent of responsibilities)
Supports quality system documents and records for completeness, scans, organizes, and files electronically and physically
Support post market surveillance activities, as needed
Executes health hazard evaluations and field action activities with direction from the Recall Coordinator. Identify scope of product holds, perform traceability, and physical quarantine of impacted products.
Investigate potential non-conformances and recommend CAPA activity to manager. Support CAPA investigations for root cause determination and action implementation/verification.