Quality Engineer II, Instrument Platform — Impact Driven

BD; Cockeysville (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

Waters seeks a Quality Engineer II to ensure ISO and regulatory compliance across the product lifecycle, applying advanced statistical tools to support new and existing product lines. You will develop and maintain Device History Files and generate CTQ indices for actionable improvements.

You will lead cross-functional efforts with R&D and Operations, drive CAPA and risk management activities, and mentor teams in Six Sigma and quality systems. This on-site role is based in Sparks, MD.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, or Regulatory Affairs.
• 2 years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• SAP transaction experience.

Responsibilities

• Champion Quality Compliance: Maintain ISO and regulatory requirements across the product lifecycle.
• Master Documentation: Develop and maintain Device History Files in full regulatory compliance.
• Drive Quality Intelligence: Generate CTQ indices and provide actionable recommendations for issues.
• Lead Product Integration: Support integration of new products into Manufacturing and Operations.

Skills

Regulatory knowledge

Six Sigma

Data analysis

Quality systems

FDA 21 CFR 820

ISO 13485

Audit experience

Statistical software

Excel

PowerPoint

Education

Bachelor's degree in Biological Sciences / Chemistry / Regulatory Affairs

Tools

SAP

Excel

PowerPoint

Job description

Waters seeks a Quality Engineer II to ensure ISO and regulatory compliance across the product lifecycle, applying advanced statistical tools to support new and existing product lines. You will develop and maintain Device History Files and generate CTQ indices for actionable improvements.

You will lead cross-functional efforts with R&D and Operations, drive CAPA and risk management activities, and mentor teams in Six Sigma and quality systems. This on-site role is based in Sparks, MD.