Job Description
Job Description
Title: Quality Engineer II
Location:
Overview:
Seeking a Quality Engineer II to support manufacturing and quality operations in a regulated medical device environment.
Must Have:
- 3+ years’ experience in the medical device industry
- Strong background in NCMR, CAPA, and product quality management
- Solid knowledge of FDA (21 CFR Part 820), ISO 13485, and EU MDR
- Experience in a clean room or regulated manufacturing environment
- Excellent problem-solving, analytical, and technical writing skills
- Proficiency in QMS and Microsoft Office
Nice to Have:
- Familiarity with DMAIC, 5 Whys, Is/Is Not analysis
- Experience with Agile Map, SAP ERP, or MES
Key Responsibilities:
- Lead and manage non-conformance (NC) and CAPA processes
- Partner with Manufacturing and Quality teams to ensure compliance
- Conduct line walks, drive process improvements, and maintain audit readiness
- Support change control and QMS documentation
Education:
- Bachelor’s degree + 2 years of experience (or advanced degree)
Company DescriptionWe believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.
Company Description
We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.