Quality Systems Leader – ISO 13485 & CAPA

Technical Needs; Chelmsford (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Technical Needs in Chelmsford, MA seeks a Quality Manager to lead the QA/QC teams in a fast-paced manufacturing setting compliant with ISO 13485:2016.

You will develop and maintain the Quality Management System, ensure regulatory compliance, and drive continuous improvement across functions. This role requires strong leadership and deep knowledge of ISO 9001/13485, AS9100, IPC-A-610, and J-STD-001, plus audits and CAPA management.

Qualifications

• Bachelor's Degree in engineering or related field.
• 5+ years of leadership in QA/Manufacturing or related discipline.
• Experience with ISO 13485/9001, AS9100, IPC-A-610, J-STD-001

Responsibilities

• Lead QA/QC teams to ensure product quality.
• Develop and maintain the QMS to meet ISO/regulatory standards.
• Direct external audits and drive CAPA and change control.
• Foster cross-department collaboration for process improvements.

Skills

Quality leadership

Regulatory compliance

CAPA management

Audits

Change control

QMS development

Cross-functional collaboration

Data analysis

Communication

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office Suite

Quality management software

Job description

Technical Needs in Chelmsford, MA seeks a Quality Manager to lead the QA/QC teams in a fast-paced manufacturing setting compliant with ISO 13485:2016.

You will develop and maintain the Quality Management System, ensure regulatory compliance, and drive continuous improvement across functions. This role requires strong leadership and deep knowledge of ISO 9001/13485, AS9100, IPC-A-610, and J-STD-001, plus audits and CAPA management.