QA Engineer II – Medical Devices Reliability

TE Connectivity; 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’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, revise and install quality control systems, develop analytical methods and establish product reliability.

The role includes root-cause analysis, CAPA, and ensuring QSRs and QMS compliance. This position reports to the Director/Quality Assurance and adheres to FDA QSR (21 CFR

Qualifications

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

Responsibilities

• Implement quality system documentation in compliance with the quality manual and SOPs.
• Develop and execute Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing.
• Develop and maintain the pFMEA process for manufacturing.
• Support/participate in regulatory agency and customer quality audits.
• Participate in design control activities to ensure product meets specifications, reliability, and manufacturability.
• Lead CAPA management to root cause analysis and corrective action implementations.
• Write and/or assist in development of protocols and engineering reports ensuring regulatory compliance.
• Work with statistics concepts and update SPC and Gage R&R studies.
• Provide quality engineering support to sending sites during project transfers.
• Collaborate with suppliers to improve product quality and resolve issues.

Skills

Quality engineering

CAPA management

Statistical methods

Problem solving

Education

BS/BA in engineering or science

AQS Certified Quality Engineer or MS in medical devices/engineering management/mechanical

Tools

SPC & Gage R&R

Regulatory audits

Job description

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, revise and install quality control systems, develop analytical methods and establish product reliability.

The role includes root-cause analysis, CAPA, and ensuring QSRs and QMS compliance. This position reports to the Director/Quality Assurance and adheres to FDA QSR (21 CFR