Trelleborg Medical Solutions is seeking a NPD Quality Engineer to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing through the design and development phases including validation for new product development.
Requirements
- Knowledge and experience with GMP/ISO Standards
- Certified Six Sigma Yellow/Green
- ASQ Certified Quality Engineer and/or Auditor
- Class I, II, and/or III Medical device manufacturing experience
- Demonstrated competence using Microsoft Office, Project, Access and JMP
- Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards
- Working knowledge of statistical methods associated with six sigma and quality control.
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 projects
- 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
Other
- 4 year degree in quality, engineering or any related field
- 5+ years in a manufacturing environment in a technical support role
- Ability to read, write, speak and understand the English language (with a translator, if necessary)
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
