Quality Engineer
Remote · United States
Job Summary
Quality Engineer responsible for quality oversight of device development and commercial manufacturing, with emphasis on supplier quality, change management, and lifecycle product quality. Oversees design control activities (design reviews, DHF, risk management), validates protocols/reports (process, test method, packaging) from internal and external partners, leads or supports change control activities and CAPA, and collaborates with internal teams and contract manufacturers to ensure compliance with GMP, ISO 13485, and 21 CFR Part 820 for nasal inhalation systems and combination products. Will participate in supplier qualification/monitoring, audits, and regulatory inspections, analyze quality data to drive continuous improvement, and ensure supplier quality management throughout product lifecycle. Remote work in the United States is supported with Eastern Time Zone consideration; W2 or 1099 employment.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5+ years of experience in medical device or combination products
- Hands-on, in-depth experience supporting quality engineering activities for nasal inhalation or drug delivery devices
- Demonstrated expertise with nasal inhalation systems, including device functionality, performance testing, and application of quality and regulatory requirements for combination products
- Experience working with contract manufacturers and supplier quality management
- Strong knowledge of design controls, risk management (ISO 14971), and GMP
- Experience supporting audits and regulatory inspections
- Strong problem-solving skills and attention to detail
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