Sr. Quality Assurance 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.

POSITION SUMMARY:
The Sr. Quality Assurance Specialist (SQAS) 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 leading and performing biennial reviews to drive continuous improvement, align best practices, procedures and applicable regulations (FDA, ISO, etc.)

• Responsible for leading impacts resulting from proposed changes to quality system procedures

• 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.

• Leads and performs internal and supplier quality system audits (for areas independent of responsibilities)

• Supports Master Audit Schedule, vendor management and leads onsite/desktop audits, and 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.

• Supports timely execution of Quality Plans, Quality System CAPAs, CAPA trending meetings and management reviews

• Investigate potential non-conformances and recommend CAPA activity to manager. Leads CAPA investigations for root cause determination and action implementation/verification.

• Distribute documents for approval and obtain signatures from team members (DocuSign)

• Supports external (FDA, ISO, etc.) compliance audits as well as schedule and manage internal audits as required to maintain quality compliance

• An associate or bachelor’s degree in life sciences is strongly preferred; in lieu of degree, a HS Diploma with 7+ years of quality experience in the medical device or related industry is required.
• A minimum of 5+ years’ experience in medical device or pharma quality systems role (e.g. Document Control, Quality Control, Quality Assurance, etc.) is required
• Prior root cause analysis training is preferred
• Quality system auditor training or certification is preferred (ISO, other)

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