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Quality Lead
Job
Groe Advisors LLC
Franklin, MA (In Person)
Full-Time
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Job Description
Quality Lead at Groe Advisors LLC Quality Lead at Groe Advisors LLC in Franklin, Massachusetts Posted in 11 days ago.
Type:
full-timeJob Description:
JOB SUMMARY
Our client is seeking an experienced, hands-on Quality Lead to lead and own the company's Quality Management System (QMS) within a regulated medical device environment and establish annual management reviews. The successful candidate will maintain and ensure compliance of site-specific QMS processes aligned with global QM while actively driving continuous improvement, regulatory readiness, and a culture of quality across the organization. This position offers a unique opportunity to directly influence compliance strategy, operational excellence, and the future growth of the Quality function.KEY RESPONSIBILITIES
Full QMS Ownership (Strategy + Execution)- Own, maintain, and continuously improve the Quality Management System to ensure regulatory compliance and operational effectiveness.
- Balance strategic oversight with daily hands-on execution of quality activities.
- Identify systemic risks and gaps, implement corrective strategies, and strengthen compliance infrastructure.
- Develop quality objectives aligned with business goals and corporate standards.
- Hands-On Quality Operations.
- Support complaint handling and investigations in coordination with global HQ. Escalate and support MDR/reportability decisions.
- Maintain and administer document control, change management, and training systems.
- Support risk management activities across the product lifecycle.
- Analyze field performance trends and implement preventive and corrective actions. Regulatory & Audit Leadership
- Serve as the primary on-site liaison during FDA inspections in coordination with global regulatory teams.
- Prepare for, host, and respond to regulatory inspections and external audits.
- Conduct and facilitate Management Review meetings, providing executive-level quality performance reporting.
- Support post-market surveillance, regulatory reporting, corrections, removals, and recall strategy development. Organizational Influence & Strategic Partnership
- Act as a trusted advisor to senior leadership on regulatory risk, compliance strategy, and quality performance.
- Drive cross-functional accountability for regulatory compliance and continuous improvement.
- Promote a strong quality culture across all departments.