NPD Quality Engineer

Location: Delano, MN, USA

About the role

Plan and coordinate quality engineering activities for medical device manufacturing through the design and development phases, including validation for new product development. Collaborate with other New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and other regulatory agencies.

Responsibilities

• Adhere to TMS Quality Management System and its requirements.
• Work with the NPD team to plan, develop, and execute equipment, software, test method, and/or process validation strategy.
• Monitor and report on project deliverables to ensure timely completion; escalate issues, questions, and concerns immediately to prevent project delays.
• Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk 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, customer documentation, and other documents to support NPD projects.
• Plan, coordinate, and oversee Test Method Development activities; initiate inspection plans for new/revised product.
• Work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications.
• Perform measurement system analysis (MSA), including Gage R&R, Bias and Linearity, Resolution, and Stability studies.
• Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, and Capability Analysis.
• Author and execute Quality Plans as needed.
• Support resolution of deviations and nonconforming issues arising during development; complete investigations and perform root cause analysis.
• Review and ensure compliance with QMS of all validation documents and records.
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to product control.
• Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects.
• Understand regulatory requirements (e.g., ISO 13485, 9001, 14971, FDA 21 CFR 820, EU/MDR, ITAR).
• Provide periodic work direction and assistance to QA inspectors and QE Technicians.
• Support other quality activities such as customer complaints, MRBs, and CAPAs.
• Drive best practices through the application of effective quality engineering principles and procedures across functions.
• Support internal and external audits.
• Perform other duties as assigned.

Requirements

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

Qualifications (Desired)

• ASQ Certified Quality Engineer.
• Formal Six Sigma Yellow/Green belt training.
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21 CFR 820/11 (4/210/211 as applicable), EU/MDR.

Benefits

• Competitive compensation: $78,000 - $97,000 annual salary.
• Generous benefits package including health, dental, vision, STD, LTD, life insurance, 401k, paid time off, and tuition reimbursement.
• Clean and climate-controlled work environment.
• Autonomy and support to lead the production team and impact the production of life-saving devices.
• Opportunities for growth and advancement within a global company that promotes from within.