Quality Engineer — Quality Systems

Job overview

The Quality Engineer — Quality Systems role is listed in Boston, MA; compensation is not specified. The description identifies support for the Madison facility and collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management to strengthen quality culture.

What you'll do

• Develop and maintain quality-system processes, metrics, and tracking
• manage CAPA initiation, review, surveillance, and reporting
• facilitate Quality Management Reviews and Change Management
• support root-cause analyses
• lead Good Documentation Practice training and Quality on the Floor coordination
• apply regulatory requirements
• coordinate facility audits
• manage recall data collection and reporting
• trend quality systems for FDA and management reviews
• improve procedures
• review and approve documentation
• support other quality-system functions
• lead personnel in support of business needs
• use Microsoft Office and statistical analysis tools such as Minitab
• perform technical writing. The description prefers a bachelor’s degree or higher in a science or technology program and cites five years of Quality Assurance experience in a cGMP environment.

What we're looking for

Skills & competencies

quality engineer

quality systems

capa

change management

cgmp

quality assurance

audits

root cause analysis

minitab

boston ma

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

The description calls the role Senior Quality Analyst/Engineer and identifies the Madison facility, while the listing location is Boston, MA. Medical-device experience is preferred.

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.