Quality Engineer IILancesoft INC • Billerica, MA, US

Quality Engineer II

Lancesoft INC • Billerica, MA, US

[job_card.30_days_ago]

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[job_card.full_time]

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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)

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