Sr. Quality Systems Specialist
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.
PRIMARY DUTIES & 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.
Qualifications
EDUCATION & EXPERIENCE:
- 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
- Prior root cause analysis training is preferred
- Quality system auditor training or certification is preferred (ISO, other)
Additional Information
All your information will be kept confidential according to EEO guidelines.
It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
Treace is a drug free employer.