Quality Engineer I – Biomedical – Haemonetics
Haemonetics is a global healthcare company providing hematology products — from blood component management to hemostasis management — that help hospitals and blood centers improve outcomes. Our Boston team is seeking a Quality Engineer I to support quality systems and product compliance for our blood management devices.
Responsibilities
- Support design quality activities including DHF reviews, design FMEAs, and risk assessments
- Execute incoming inspection, in-process, and final product quality audits
- Assist with nonconformance investigations, CAPAs, and supplier quality issues
- Contribute to process validation (IQ/OQ/PQ) activities and statistical process control
- Maintain quality records in eQMS system and ensure compliance with 21 CFR Part 820 and ISO 13485
- Support FDA inspections and notified body audits as needed
Requirements
- BS in Biomedical Engineering, Quality Engineering, or related field (0-2 years experience)
- Coursework or experience in quality management systems preferred
- Familiarity with Minitab or statistical analysis tools
- Strong attention to detail and ability to manage multiple tasks
- CQE certification pursuit encouraged; ASQ student membership a plus
Benefits
- Competitive salary with clear advancement pathways
- Health, dental, and vision insurance from day one
- 401(k) with employer match
- Paid holidays and PTO
- Support for CQE and professional certifications