Quality Systems Supervisor: ISO 13485 & CAPA Leader

TE Connectivity Corporation; Medway (MA); On-site; USD 93,000 - 116,000; Full time

Benefits offered by this job

Health insurance

401(k)

Disability insurance

Life insurance

Employee stock purchase plan

Paid time off

Voluntary benefits

Job summary

TE Connectivity seeks a Quality Systems Engineer Supervisor for the Medway, MA site. This 100% onsite role owns and drives the Quality System processes to ensure ISO 13485 compliance, audit readiness, and continuous improvement across the site.

Responsibilities include leading CAPA, audits, investigations, change control, and data-driven management reviews while collaborating with cross-functional teams to sustain quality performance and regulatory compliance.

Qualifications

• Strong knowledge of ISO13485 and regulatory requirements.
• Experience in CAPA, auditing, and audit support.
• Proven ability to lead investigations and root cause analysis.
• Experience with eQMS data management and reporting.
• Ability to collaborate cross-functionally and influence stakeholders.

Responsibilities

• Own and maintain Quality System processes in compliance with ISO 13485.
• Lead internal and external audits and close findings.
• Manage CAPA activities and verify effectiveness.
• Oversee Customer Complaints and RMA processes.
• Prepare Management Review inputs for Quality Systems.

Skills

ISO 13485

CAPA

Internal auditing

Customer complaints

eQMS software

Cross-functional

Root cause analysis

Communication

Education

Bachelor’s degree in Engineering/Science/Quality

Tools

eQMS software

Job description

TE Connectivity seeks a Quality Systems Engineer Supervisor for the Medway, MA site. This 100% onsite role owns and drives the Quality System processes to ensure ISO 13485 compliance, audit readiness, and continuous improvement across the site.

Responsibilities include leading CAPA, audits, investigations, change control, and data-driven management reviews while collaborating with cross-functional teams to sustain quality performance and regulatory compliance.