Quality Manager

AppLab Systems, Inc; Reedsville (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

AppLab Systems, Inc in Reedsville, PA is seeking a Quality Manager to lead QMS, CAPA, nonconformance, complaint and audit programs for medical devices, ensuring FDA and ISO 13485 compliance.

Responsibilities include supporting FDA inspections, driving remediation, monitoring quality metrics, and leading cross-functional quality improvements across teams.

Qualifications

• Experience leading QMS and quality improvement initiatives.
• Proven ability to support FDA inspections and regulatory audits.
• Strong knowledge of regulatory standards (FDA, ISO 13485).

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.

Skills

Medical Device QMS

CAPA, Nonconformance, Complaint, and 4

FDA 21 CFR Part 820/QMSR ISO 13485

Risk Management and Design Controls

Quality Metrics and Remediation

Education

Bachelor's or Master's degree in Engineering or related discipline

Tools

ISO 13485 Lead Auditor or ASQ/CQI certification

Job description

Role: Quality Manager

• 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.

Location:

Reedsville, PA (Day 1 Onsite)

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.

Preferred Qualifications:

• 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