Quality Systems Lead — ISO 13485 & CAPA Expert

TE Connectivity; Medway (MA); On-site; USD 92,900 - 116,100; 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 is seeking a Senior Quality Systems Engineer at the Medway, MA site to own and drive Quality System processes, including CAPA, audits and customer complaint handling. You will lead investigations, drive improvements, and ensure ongoing audit readiness.

This role requires strong cross‑functional collaboration and deep ISO 13485 knowledge. At TE Connectivity, you will contribute to a safety‑driven, quality‑minded culture, lead process improvements, and mentor teams while

Qualifications

• Bachelor’s degree in Engineering, Science, Quality or related field.
• Minimum 5 years of related experience with a Bachelor’s degree; or 3 years with a Master; or a PhD without experience.
• ISO 13485 Auditor training or Lead Auditor preferred.
• Quality Assurance qualification preferred.

Responsibilities

• Own and maintain assigned Quality System processes and ensure compliance with ISO 13485 and regulatory requirements.
• Lead internal and external audits, coordinate stakeholders, and close audit findings.
• Drive CAPA activities including investigation, root cause analysis, corrective/preventive actions, and verification of effectiveness.
• Oversee Customer Complaint and RMA processes, ensuring timely investigations and closure.
• Oversee change control processes and train requirements across Quality Systems.
• Develop and communicate Quality Systems metrics; lead Management Review inputs.

Skills

ISO 13485 knowledge

CAPA & internal audits

eQMS experience

Cross-functional collaboration

Problem solving

Quality metrics & reporting

Education

Bachelor’s degree in Engineering/Science/Quality or related

Tools

eQMS software

Job description

TE Connectivity is seeking a Senior Quality Systems Engineer at the Medway, MA site to own and drive Quality System processes, including CAPA, audits and customer complaint handling. You will lead investigations, drive improvements, and ensure ongoing audit readiness.

This role requires strong cross‑functional collaboration and deep ISO 13485 knowledge. At TE Connectivity, you will contribute to a safety‑driven, quality‑minded culture, lead process improvements, and mentor teams while