Senior QA Manager – Medical Devices & QMS

hg medical GmbH & USA; Holland (MI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Leadership role in expanding facility

Job summary

HG Medical seeks an experienced QA Manager to lead the site Quality Management System, drive regulatory compliance, and develop the QA team. You will own QA activities including documentation practices, change control, CAPA, audits, supplier quality, validation, and transfer readiness on the manufacturing floor.

The role collaborates with QC, Operations, Engineering, Supply Chain, and customers to ensure products meet customer and regulatory requirements and to maintain patient safety.

Qualifications

• Bachelor’s degree in quality, engineering, manufacturing, life sciences, or related field.
• Seven or more years of quality experience in regulated manufacturing.
• Experience with ISO 13485 and FDA medical device requirements.
• Experience leading external audits or regulatory inspections.
• Strong communication and leadership on manufacturing floor.

Responsibilities

• Lead and maintain the site QMS in line with regulations and standards.
• Manage QA personnel and coordinate with QC, Operations, and Engineering.
• Prepare for FDA inspections and ISO certification audits.
• Drive nonconformance investigations and CAPA with timely closure.

Skills

Quality leadership

Audit readiness

CAPA investigations

Change control

Nonconformance

Documentation practices

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in quality, engineering, manufacturing, life sciences, or related field

Tools

ERP systems

Document control software

Calibration management

Job description

HG Medical seeks an experienced QA Manager to lead the site Quality Management System, drive regulatory compliance, and develop the QA team. You will own QA activities including documentation practices, change control, CAPA, audits, supplier quality, validation, and transfer readiness on the manufacturing floor.

The role collaborates with QC, Operations, Engineering, Supply Chain, and customers to ensure products meet customer and regulatory requirements and to maintain patient safety.