NPD Quality Engineer: Medical Device Validation & QA

Trelleborg Sealing Solutions US Inc; Delano (MN); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Generous benefits package

Clean work environment

Greater impact and autonomy

Growth and advancement

Job summary

Trelleborg Medical Solutions is seeking an NPD Quality Engineer to plan and coordinate quality engineering activities for medical device development. You will support equipment qualification, software validation, test method development/validation, and process validation (IQ/OQ/PQ) to ensure compliance with FDA, ISO 13485, and EU/MDR as applicable.

You will collaborate with internal teams to drive quality across development stages and work under a strong QMS, ensuring timely project delivery and

Qualifications

• Bachelor's degree in quality, engineering or related field.
• ASQ CQE certification preferred or required.
• Experience with GMP/ISO standards (FDA/13485) in medical device manufacturing.
• 2+ years in a manufacturing environment in a technical support role.

Responsibilities

• Follow and improve TMS Quality Management System and requirements.
• Plan, develop and execute equipment, software, test method and process validation strategies.
• Monitor project deliverables and report status; escalate issues to avoid delays.
• Perform risk management using PFMEA and other risk tools.
• Prepare and review validation protocols and reports (IQ/EQ, SV, TMV, OQ/PQ).
• Support deviations, nonconformances, investigations and root-cause analyses.
• Ensure compliance with QMS across validation documents and records.
• Assist engineering, manufacturing and inspection teams with validation and control activities.
• Communicate with customers on specifications, documentation and process changes.

Skills

Quality engineering

GMP/ISO knowledge

Regulatory compliance

Statistical analysis

Education

ASQ Certified Quality Engineer

Tools

QA methodologies

Job description

Trelleborg Medical Solutions is seeking an NPD Quality Engineer to plan and coordinate quality engineering activities for medical device development. You will support equipment qualification, software validation, test method development/validation, and process validation (IQ/OQ/PQ) to ensure compliance with FDA, ISO 13485, and EU/MDR as applicable.

You will collaborate with internal teams to drive quality across development stages and work under a strong QMS, ensuring timely project delivery and