Senior Quality Engineer

We are seeking a Quality Engineer to support product development and cleanroom manufacturing activities. The role will ensure compliance with quality systems and regulatory standards while supporting risk management, validation, and design control documentation.

Responsibilities:

• Support quality engineering activities for product development and cleanroom build.

• Ensure NPD processes comply with quality systems and regulatory requirements.

• Update and maintain risk management files and design control documentation.

• Develop and execute test method validation and qualification plans.

• Support design verification, process validation, and multi-site transfers.

• Collaborate with R&D, Manufacturing, Regulatory, and cross-functional teams.

• Maintain accurate quality documentation and reports.

Required Qualifications:

• Bachelor s degree in Engineering or Scientific field with 4+ years of experience
  OR Master s degree with 3+ years of experience.

• Experience in quality, product development, or regulated manufacturing.

• Understanding of ISO 13485 and quality systems.

• Experience with risk management documentation.

• Knowledge of test method validation and basic statistics (Minitab preferred).

• Strong documentation, communication, and problem-solving skills.