Quality Manager

Lorven Technologies Inc

Hi,

Our client is looking for Quality Manager in Reedsville, PA below is the detailed requirement.

Job Title: Quality Manager

Location: Reedsville, PA

Job Description:

Bachelor's or Master's degree in Engineering or related discipline.
12+ years of Medical Device Quality experience.
5+ years of Quality Management leadership experience.
ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
Experience supporting FDA inspections and remediation programs 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.
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.
Excellent communication and presentation skills, with the ability to explain complex technical concepts to both technical and non-technical audiences.
Lead Automation Transformation & Provide Visibility to Business Segment & Leadership

Apply

Vacancy posted 3 days ago

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