What are the responsibilities and job description for the NPD Quality Engineer position at Trelleborg Brand?
Trelleborg Healthcare and Medical is seeking a NPD Quality Engineer to join their team. Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.
As a valued Trelleborg team member, you will enjoy:
- Greater opportunity for impact
- Competitive compensation
- Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
- Paid time off
- Quarterly Bonus
Pay: $80,000 - $90,000 per year
Qualifications:
Required:
• 4 year degree in quality, engineering or any related field
• 2 years in a manufacturing environment in a technical support role
Desired:
• ASQ Certified Quality Engineer
• Formal Six Sigma Yellow/ Green belt training
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
Responsibilities:
• In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategy
• Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk 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), Process validation (OQ/PQ)
• Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD project
• Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product
• Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications
• Perform measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies
• Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis
• Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects
• Initiate and perform root cause analysis, using statistical and capability analysis to solve problems
• Adhere to the company’s Quality System (QS), write, and approve QS documents
• 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 the control of product
• Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed
• Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR)
• Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians
• Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA),
• Support internal and external audits
• Other duties as assigned
Salary : $80,000 - $90,000
