Quality Engineer

Responsibilities

• Support manufacturing and process development activities to ensure product quality and compliance
• Participate in process validation activities, including IQ, OQ, and PQ protocols and reports
• Support test method validation and verification activities
• Investigate non-conformances and assist with CAPA activities
• Collaborate with Manufacturing, Engineering, and Regulatory teams to identify and resolve quality-related issues
• Contribute to risk management activities, including FMEAs and control plans
• Analyze quality data and identify opportunities for continuous improvement
• Aid in maintaining quality system documentation, including DHF, DMR, and DHR records

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• 2+ years of quality engineering experience within a regulated industry
• Experience in medical device, pharmaceutical, biotechnology, or other FDA-regulated environments preferred
• Familiarity with quality systems and applicable regulations, including FDA and ISO standards
• Exposure to process validation, non-conformance investigations, CAPA, or risk management activities
• Ability to interpret engineering drawings and technical documentation
• Strong analytical, problem-solving, and communication skills
• Ability to manage multiple priorities in a fast-paced environment