Remote Quality Systems Leader, Medical Devices

BIOTRONIK; Lake Oswego (OR); Remote; USD 110,000 - 150,000; Full time

Job summary

BIOTRONIK is seeking a Quality Systems Manager to maintain the Quality Management System (QMS) and ensure compliance with medical device regulations and standards. The role leads quality systems activities across internal quality, product quality and distribution to support regulatory requirements and organizational goals.

The successful candidate will partner with cross-functional teams, drive continuous improvement, and provide technical leadership to strengthen quality capabilities across the

Qualifications

• Understanding of risk management and quality systems requirements.
• Experience with FDA/ISO quality regulations and audits.
• Ability to communicate regulatory requirements across levels.

Responsibilities

• Manage Quality Systems activities in accordance with regulations and company policies.
• Lead internal/external audits and support inspections by regulators.
• Drive continuous improvement of quality processes and systems.

Skills

Risk management

Supplier quality

Complaint management

Quality systems

Regulatory communication

Analytical skills

Problem solving

Education

Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences

Advanced degree preferred

Job description

BIOTRONIK is seeking a Quality Systems Manager to maintain the Quality Management System (QMS) and ensure compliance with medical device regulations and standards. The role leads quality systems activities across internal quality, product quality and distribution to support regulatory requirements and organizational goals.

The successful candidate will partner with cross-functional teams, drive continuous improvement, and provide technical leadership to strengthen quality capabilities across the