Principal Quality Engineer — Regulated Products

Job overview

The Principal Quality Engineer — Regulated Products role is onsite in Guilderland, NY. Compensation is not specified. The role provides quality engineering leadership across product development, manufacturing and sustaining engineering. The role exists to guide quality strategy and regulatory compliance throughout the product lifecycle. It contributes to product and operational goals by strengthening quality systems, leading investigations and corrective actions, managing risk, supporting validation and audits, and mentoring quality engineers.

What you'll do

• Lead quality engineering across development, manufacturing and sustaining engineering
• plan quality for new product introduction, design transfer, validation and manufacturing readiness
• improve QMS processes
• lead nonconformance, complaint and quality investigations and CAPA
• maintain risk documentation
• support qualification and validation
• analyze quality metrics
• lead supplier quality initiatives and audits
• ensure regulatory compliance
• mentor Quality Engineers
• drive Lean, Six Sigma and continuous improvement.

What we're looking for

Skills & competencies

principal quality engineer

full-time

guilderland ny

katalyst healthcares & life sciences

quality engineering

regulatory compliance

medical devices

qms

capa

risk management

supplier quality

continuous improvement

Work arrangement

• Weekend coverage required

Why this role

Requires a relevant bachelor’s degree and 10 years of quality engineering experience in a regulated industry. Preferred qualifications include ASQ CQE, Six Sigma Green or Black Belt, and experience with listed QMS tools.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.