Responsibilities:

• Provide quality engineering support for new and existing medical devices, ensuring adherence to all applicable quality system regulations.
• Conduct non-conformance investigations, including root cause analysis, documentation, and approval of material dispositions. Take prompt corrective actions to address quality concerns.
• Validate manufacturing processes, including equipment qualification and test method validations.
• Collaborate with manufacturing engineering to implement process controls and validations in accordance with industry standards (GMP).
• Assist in developing and editing standard operating procedures (SOPs) and support internal and external audits.

Qualifications:

• Bachelor's degree in a related engineering field.
• 2 years of QA/QE experience in the medical device industry.
• Proficiency in formal problem-solving methodologies.
• Strong understanding of FDA Quality System Regulations, ISO13485, and ISO14971.
• Experience in handling non-conforming materials and conducting root cause investigations.