Quality Manager

Programmers.io; Reedsville (PA); On-site; USD 120,000 - 190,000; Full time

Job summary

Programmers.io is seeking a senior quality leader to orchestrate remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. You will provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and ongoing improvement across cross-functional teams.

You will lead QMS, CAPA, Nonconformance, Complaint, and Audit programs; support FDA inspections and regulatory audits; drive remediation and compliance

Qualifications

• QMS leadership for medical devices
• CAPA governance and nonconformance management
• FDA 21 CFR Part 820/QMSR and ISO 13485 familiarity
• Risk management and design controls
• Quality metrics and remediation programs

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

QMS Leadership

CAPA governance

FDA & ISO13485 knowledge

Audit management

Risk management

Design controls

Education

Bachelor’s or Master’s in engineering or related field

Job description

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