NPD Quality Engineer

Trelleborg Medical Solutions is seeking a NPD Quality Engineer to join their team. The role involves planning and coordinating quality engineering activities for medical device manufacturing through design and development phases, including validation for new product development.

About the role

• Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, and process development/validation (IQ/OQ/PQ)
• Ensure compliance with the company’s Quality System and applicable external requirements and standards, including FDA, ISO 13485, and other regulatory agencies
• Work with internal and external customers to develop creative solutions to problems
• Enjoy a clean, climate-controlled work environment and opportunities for growth within a global company

Responsibilities

• Adhere to TMS Quality Management System and its requirements
• Plan, develop, and execute validation strategies for equipment, software, test methods, and processes
• Monitor and report on project deliverables; escalate issues to prevent delays
• Perform risk management using tools such as Process Failure Modes and Effects Analysis (pFMEA)
• Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software Validation (SV), Test Method Validation (TMV), and Process Validation (OQ/PQ)
• Review and evaluate specifications, drawings, quality agreements, and customer documentation
• Plan and oversee Test Method Development activities; initiate inspection plans for new/revised products
• Recommend equipment, sampling plans, and measurement techniques for inspection specifications
• Perform Measurement System Analysis (MSA), including Gage R&R, Bias, Linearity, Resolution, and Stability studies
• Conduct statistical analysis of inspection data, process characterization, Design of Experiments (DOE), ANOVA, and Capability Analysis
• Author and execute Quality Plans as needed
• Resolve deviations and nonconforming issues; complete investigations and root cause analysis
• Ensure compliance of all validation documents and records with the QMS
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, and validations
• Communicate with customers on specifications, complaints, process changes, and other projects
• Understand regulatory requirements (e.g., ISO 13485, 9001, 14971, FDA 21 CFR 820, EU/MDR, ITAR)
• Provide work direction to QA inspectors and QE Technicians
• Support quality activities such as customer complaints, MRBs, and CAPAs
• Drive best practices through effective quality engineering principles
• Support internal and external audits
• Perform other duties as assigned

Requirements

• 4-year degree in quality, engineering, or a related field
• 2+ years of experience in a manufacturing environment in a technical support role

Qualifications

• ASQ Certified Quality Engineer (desired)
• Formal Six Sigma Yellow/Green Belt training (desired)
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21 CFR 820/11, EU/MDR

Skills

• FMEA
• Measurement System Analysis (MSA)
• Gage R&R
• Design of Experiments (DOE)
• ANOVA

Benefits

• Competitive compensation: $78,000 - $97,000 annual salary
• Health, dental, and vision insurance
• Short-term and long-term disability (STD/LTD)
• Life insurance
• 401k retirement plan
• Paid time off
• Tuition reimbursement

Pay

$78,000 – $97,000 annual salary

Schedule

Standard full-time schedule (on-site)