Quality Engineer III – Medical Device Process & CAPA Lead

Hollister Incorporated; Stuarts Draft (VA); On-site; USD 65,000 - 115,000; Full time

Job summary

Hollister Incorporated in Stuarts Draft, VA is seeking a Quality Engineer to support change controls, CAPAs, QNs, process capability studies and related quality activities on the manufacturing floor.

Bachelor’s degree in engineering or related science; 0–5 years experience in quality engineering; familiarity with 21 CFR 820 and ISO 13485; knowledge of Minitab, SAP/ERP, and MS Office is preferred. ASQ CQE and lean Six Sigma knowledge are desirable.

Qualifications

• Bachelor’s degree in Science (Engineering, Math or related field).
• 0–5 years experience in quality engineering preferred.
• Experience with medical device QMS per 21 CFR 820/ISO 13485 preferred.
• ASQ CQE preferred.

Responsibilities

• Act as Quality Resource to help facilitate completion of assigned Change Controls.
• Lead and perform pFMEA and products/process qualifications.
• Review, evaluate and disposition non-conforming materials.
• Respond to assigned CAPAs and QNs for investigation, root cause analysis and implement solutions.
• Plan, coordinate, execute and document process capability, validation studies, and process improvement studies.
• Create, execute and conclude results for protocols, including final reports and summaries.
• Support Operations and GQM strategic plans in leading or supporting projects.
• Plan, coordinate, and document Quality Plans and work instructions.
• Conduct training on defect awareness.
• Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues.

Skills

Basic statistics

Minitab

Technical writing

Audits

Lean Six Sigma

Education

Bachelor's degree in Science/Engineering

Tools

SAP/ERP

Microsoft Office

Job description

Hollister Incorporated in Stuarts Draft, VA is seeking a Quality Engineer to support change controls, CAPAs, QNs, process capability studies and related quality activities on the manufacturing floor.

Bachelor’s degree in engineering or related science; 0–5 years experience in quality engineering; familiarity with 21 CFR 820 and ISO 13485; knowledge of Minitab, SAP/ERP, and MS Office is preferred. ASQ CQE and lean Six Sigma knowledge are desirable.