Sr. Quality Systems Specialist

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

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.

• 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 Solid Works 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 Docu Sign 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.

• 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)

All your information will be kept confidential according to EEO guidelines.

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