Senior Quality Engineer: CAPA, Change Mgmt & Data Analytics

Katalyst-Healthcares-; 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

Job Summary:

• The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and products related to CAPA, Change Management, investigations, deviations, Quality Management Review, audit coordination, and metrics are effectively managed for the Madison facility.
• The role will also support Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Roles & Responsibilities:

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate site Quality Management Reviews.
• Facilitate and lead the site Change Management process.
• Support and lead root cause analyses through cross-functional team involvement.
• Lead Good Documentation Practice training and Quality on the Floor coordination and performance.
• Interpret and properly apply all applicable regulatory requirements.
• Coordinate and provide direct support for facility audits by internal and external entities.
• Manage data collection and reporting when product recalls are required.
• Perform trending of Quality Systems to support FDA and Management reviews.
• Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements.
• Review and approve procedures, protocols, reports, etc., as required.
• File and manage documentation when required.
• Support other Quality System Functions.
• Lead personnel, inside and outside the Quality organization, in support of business needs.
• Utilize Microsoft Office tools, especially Excel, Word, and PowerPoint.
• Perform technical writing.
• Utilize statistical analysis, including Minitab or equivalent software, for trending and interpretation of statistical data.

Education & Experience:

• Bachelor's degree or higher in a science/technology program preferred.
• 5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment, with medical devices preferred.
• Effective communication, coaching/mentoring, and presentation skills.
• Ability to manage change.
• Self-motivated with independent and sound decision-making capabilities.
• Project management skills to deliver on-time results.
• Leadership skills / Emotional Intelligence.
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data.