Quality Manager

Role: Quality Manager

Location: Reedsville, PA (Onsite)

Fulltime OR Contract

Job Summary:

Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes,

audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.

Key Responsibilities:

 Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.

 Support FDA inspections and regulatory audits.

 Drive quality remediation and compliance initiatives.

 Monitor quality metrics and management reviews.

 Lead cross-functional quality improvement activities.

Required Skills:

 Medical Device Quality Management Systems (QMS).

 CAPA, Nonconformance, Complaint, and Audit Management.

 FDA 21 CFR Part 820/QMSR and ISO 13485.

 Risk Management and Design Controls.

 Quality Metrics, Remediation, and Compliance Programs.

Dipendra Gupta

Technical Recruiter

[email protected]