Senior Quality Engineer: CAPA, Change Mgmt & Data Analytics

Creative Solutions Services, LLC; Boston (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Quality Analyst/Engineer to assure CAPA, Change Management, investigations, deviations, and quality system activities at the Madison facility. The role supports data maintenance, trending, and regulatory collaboration to drive quality culture.

Responsibilities include leading QA processes, audits, and cross-functional root cause analyses, with a focus on improving procedures to comply with regulatory requirements and FDA expectations.

Qualifications

• Bachelor's degree in science/technology preferred.
• 5+ years of Quality Assurance in a cGMP environment, medical devices preferred.
• Strong written and verbal communication, coaching and presentation skills.
• Ability to manage change and drive continuous improvement.
• Self-motivated with independent decision-making and project management skills.
• Leadership skills and emotional intelligence.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate site Quality Management Reviews.
• Lead Change Management processes and cross-functional investigations.
• Support root cause analyses with cross-functional teams.
• Provide training and coordination for Quality on the Floor activities.

Education

Bachelor's degree in science/technology

Tools

Microsoft Office (Excel, Word, PowerPoint)

Minitab or equivalent

Job description

Creative Solutions Services, LLC seeks a Senior Quality Analyst/Engineer to assure CAPA, Change Management, investigations, deviations, and quality system activities at the Madison facility. The role supports data maintenance, trending, and regulatory collaboration to drive quality culture.

Responsibilities include leading QA processes, audits, and cross-functional root cause analyses, with a focus on improving procedures to comply with regulatory requirements and FDA expectations.