Internal Quality Systems Auditor

Quality Systems Auditor: This role serves as a key quality compliance resource, ensuring that quality systems, suppliers, and processes consistently meet FDA, ISO, client, and internal quality requirements, * Plan, schedule, conduct, and report internal quality system audits in accordance with corporate internal auditing and local business unit audit programs

• Perform qualification and requalification supplier/vendor audits to evaluate compliance with regulatory, quality, and contractual requirements.
• Evaluate the effectiveness of quality management systems by way of performing directed and non-directed audits
• Prepare comprehensive audit plans, checklists, reports, and executive summaries.
• Document audit observations, nonconformances, risks, and opportunities for improvement.
• Present audit findings to management, clients, suppliers, and cross-functional teams.
• Maintain accurate audit records within designated quality systems.
• Serve as a primary point of contact for audit-related communications with clients and vendors.
• Coordinate audit logistics and schedules with internal and external stakeholders.
• Facilitate discussions regarding audit findings, remediation plans, and compliance expectations.
• Review and evaluate supplier responses to audit observations.
• Support continuous improvement initiatives across the quality management system.
• Analyze audit trends and metrics to identify systemic issues and improvement opportunities.

• Collaborate with Quality Assurance, Regulatory Affairs, Operations, and Engineering teams to strengthen compliance and quality processes., Emily Donahue Regional Recruiting Manager

• Directs the recruitment efforts for both the Quincy, MA and Providence, RI branches.
• Manages a distributed team of recruiting leads, individual contributor recruiters and account managers.
• Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region.

• Bachelor’s degree in scientific, engineering, quality, regulatory, or related discipline preferred. Equivalent combination of education and experience may be considered
• ISO 13485:2016 lead auditor certificate required

Experience:

• Minimum 3-5 years of experience in Quality Assurance, Quality Systems, Compliance, or Auditing within the medical device industry.
• Experience conducting internal audits and supplier/vendor audits.
• Experience working within FDA-regulated environments.

Strong knowledge of:

• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• ISO 13485
• Strong technical writing and report generation skills.
• Excellent verbal and written communication skills.
• strong organizational and project management skills.
• ability to travel periodically for supplier, client, and internal audits., * 21 CFR Part 58
• 21 CFR Part 14155
• Risk Management principles (ISO 14971)
• Experience supporting FDA inspections and notified body audits.
• Experience auditing software validation and electronic quality systems subject to Part 11 requirements.
• Experience with contract