Senior Quality Systems Engineer & Audit Lead

TE Connectivity; 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 Medway site is seeking a Senior Quality Systems Engineer to own and continuously improve Quality System processes in alignment with ISO 13485, ensuring audit readiness and cross-functional collaboration across the site. The role requires a Bachelor’s degree in Engineering/Science/Quality and 5+ years of experience (or 3 years with a Master/PhD) with CAPA, auditing, and eQMS exposure.

The position is onsite in Medway, MA, with a focus on driving compliance and continuous

Qualifications

• Bachelor’s degree in Engineering, Science, Quality or related discipline.
• 5+ years of related experience with a Bachelor’s degree; or 3 years with a Master’s; or PhD without experience.
• ISO 13485 Auditor training and/or Lead Auditor qualification preferred.
• Strong knowledge of ISO13485 and regulatory requirements.
• Experience leading CAPA, audits, and investigations.

Responsibilities

• Own and maintain Quality System processes ensuring compliance with internal procedures and ISO 13485.
• Lead internal and external audits, coordination, and closure of findings.
• Manage CAPA activities including root cause analysis and verification of effectiveness.
• Oversee Customer Complaints and RMA processes at site level.
• Drive change control, training, and documentation to maintain compliance.
• Develop Quality Systems metrics and support Management Review inputs.

Skills

ISO 13485 knowledge

CAPA & investigations

Internal auditing

eQMS experience

Cross-functional collaboration

Problem solving & communication

Education

Bachelor’s degree in Engineering/Science/Quality

Tools

eQMS software

Job description

TE Connectivity Medway site is seeking a Senior Quality Systems Engineer to own and continuously improve Quality System processes in alignment with ISO 13485, ensuring audit readiness and cross-functional collaboration across the site. The role requires a Bachelor’s degree in Engineering/Science/Quality and 5+ years of experience (or 3 years with a Master/PhD) with CAPA, auditing, and eQMS exposure.

The position is onsite in Medway, MA, with a focus on driving compliance and continuous