Quality Lead

Title
:
Quality Lead

Location
:
St. Paul, MN

Job Type
:
Permanent

Compensation
: $30-35/hr

Industry
:
Medical Supplies

About The Role

Our firm is partnering with an established, regulated manufacturing organization in the medical device and life sciences space that supports high-quality, mission-critical products used in healthcare applications. We are seeking a Quality Lead to serve as the owner and champion of the organization’s Quality Management System (QMS). This is a highly visible, hands‑on leadership role responsible for ensuring compliance with applicable standards, supporting audit readiness, and fostering a culture of continuous improvement and quality excellence across the organization.

Job Description

The Quality Lead is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS). This individual acts as the subject matter expert for quality systems, audit readiness, documentation control, training, nonconformance management, and cross‑functional quality initiatives. The role balances strategic oversight with day‑to‑day execution, partnering closely with leadership and operations to ensure compliance with ISO standards, customer requirements, and applicable regulatory frameworks.

Key Responsibilities

• Own and maintain the QMS to ensure compliance with ISO and applicable regulatory requirements.
• Evaluate system effectiveness and implement improvements to drive scalability, efficiency, and compliance.
• Create, revise, and control QMS documentation including procedures, work instructions, and forms.
• Maintain strong document control practices and ensure record accuracy, traceability, and archival integrity.

• Serve as the primary Quality representative across departments and in leadership discussions.
• Provide QMS guidance, clarification, and coaching to associates and leadership.
• Participate in tier meetings, leadership huddles, and cross‑functional initiatives to integrate quality into daily operations.
• Professionally communicate risks, opportunities, and compliance concerns with appropriate urgency and transparency.

• Lead the QMS training program, including onboarding, refresher training, and ongoing awareness.
• Maintain training records and report gaps or overdue requirements to leadership.

• Lead investigations and resolution of NCRs, CARs, customer complaints, and other quality events.
• Facilitate root cause analysis (RCA) and oversee corrective and preventive actions (CAPAs).
• Ensure timely, compliant closure of CARs, DCNs, and complaint records.

• Manage customer complaints and coordinate investigations and responses.
• Interface with customers and suppliers during audits, inquiries, and escalations as required.
• Support supplier corrective action activities (SCARs) when applicable.

• Plan and conduct internal audits across departments.
• Serve as lead host and representative during customer, ISO, and regulatory audits.
• Conduct mock audits and gap analyses to maintain ongoing audit readiness.

• Define and track quality KPIs, including NCRs, CARs, complaints, audit findings, and training compliance.
• Analyze data to identify trends and systemic improvement opportunities.
• Present reports and dashboards to leadership with actionable recommendations.
• Participate in the Material Review Board (MRB) and support nonconforming material disposition.
• Lead or support Lean, Six Sigma, and continuous improvement initiatives.

• Escalate significant quality risks to leadership.
• Stay current on regulatory requirements and industry trends.
• Support departmental coverage and perform additional quality‑related duties as needed.
• Adhere to company health, safety, and cleanroom requirements.

Qualifications

• Minimum 3 years of experience in a medical device, biotech, or other regulated manufacturing environment.
• Working knowledge of ISO 9001 and current Good Manufacturing Practices (cGMP).
• Minimum 3 years of…