Quality Engineer II - Medical Devices & CAPA

TE Connectivity Corporation; Plymouth (MN); On-site; USD 83,000 - 124,000; 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 is seeking a Quality Engineer in the United States to support QSR/QMS compliance and drive continuous improvement in medical device manufacturing. You will implement质量 control systems, perform CAPA investigations, and collaborate with cross-functional teams to ensure regulatory compliance and product reliability.

Candidate should have a BS/BA in engineering or science, relevant MS or certifications, and at least 3 years in a regulated medical device environment.

Qualifications

• BS/BA degree with scientific/engineering emphasis required.
• AQS Certified Quality Engineer or MS in medical devices or related field is preferred.
• Six Sigma Green/Black belt recommended.
• Minimum 3 years’ experience in a regulated medical device environment.

Responsibilities

• Develop and implement quality control systems and processes.
• Perform CAPA investigations and drive root cause analysis.
• Support regulatory audits and ensure compliance with QSR/ISO 13485.
• Write protocols and technical investigations ensuring regulatory compliance.

Skills

CAPA management

Root cause analysis

Gage R&R

Statistical methods

Education

BS/BA degree in engineering or science

MS in Medical devices engineering or Engineering Management or Mechanical

Six Sigma Green/Black belt

Job description

TE Connectivity is seeking a Quality Engineer in the United States to support QSR/QMS compliance and drive continuous improvement in medical device manufacturing. You will implement质量 control systems, perform CAPA investigations, and collaborate with cross-functional teams to ensure regulatory compliance and product reliability.

Candidate should have a BS/BA in engineering or science, relevant MS or certifications, and at least 3 years in a regulated medical device environment.