Senior Design Assurance Quality Engineer

Teleflex; Maple Grove (MN); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

PTO and parental leave

Job summary

Teleflex seeks a Quality Engineer III, Design Assurance to drive quality throughout new product development and transfer. You will uphold the Quality System, apply best-practice tools, and collaborate with R&D, Regulatory, and Operations to ensure robust design controls.

Responsibilities include design verification/validation, risk management, statistical analysis, and CAPA leadership to maintain compliance and product safety across the lifecycle.

Qualifications

• 3–5 years of quality engineering or design assurance experience, preferably in medical devices.
• Bachelor's degree in engineering or science; ASQ certification preferred.
• Strong knowledge of ISO 13485, ISO 14971 and FDA 21CFR820.

Responsibilities

• Partner with R&D, Marketing, Regulatory, and Operations on design verification and validation.
• Create risk files with risk analyses and CAPA plans; support post-market data analysis.
• Apply statistical tools to analyze data and support decision making.
• Perform audits of Design History Files and assist internal/external audits.
• Define control methods, design FMEA, and ensure Quality System compliance.

Skills

Quality engineering

Design assurance

Statistical analysis

CAPA

Root cause analysis

Education

Bachelor's degree in engineering or science

Tools

MS Office

Minitab

Job description

Teleflex seeks a Quality Engineer III, Design Assurance to drive quality throughout new product development and transfer. You will uphold the Quality System, apply best-practice tools, and collaborate with R&D, Regulatory, and Operations to ensure robust design controls.

Responsibilities include design verification/validation, risk management, statistical analysis, and CAPA leadership to maintain compliance and product safety across the lifecycle.