NPD Quality Engineer

• 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.
• 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.

• Train company personnel as needed in areas such as the use of equipment, inspection methods, statistical methods, processes, and quality system.
• Serve as project team leader on projects. Schedule project activities and strive to meet deadlines.
• Provide mentorship to other Quality Engineers and Technicians through experiences and education as opportunities arise.
• Develop ideas and strategies to improve operational efficiency, add value, aid business performance, and work towards a culture of continuous improvement.
• Successfully manage multiple projects simultaneously.
• Drive best practices through the application of effective quality engineering principles and procedures across functions.

• 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).
• Senior level: including all the above, 5 years in a regulated manufacturing environment.
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable).

• 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.
• Ability to demonstrate adequate job knowledge to deliver a world class performance.
• Ability to challenge oneself to consistently meet all goals and deadlines.
• Willingness to strive for excellence by producing work that is free of errors and mistakes.
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately.
• Commitment to making improvements company wide.
• 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.
• Able to perform math functions.
• Effective project leader.
• Experience with lean manufacturing principles and their implementation.
• Good hand/eye coordination and depth perception.
• Good manual dexterity.
• Correctable normal reading distance vision.

Salary : $78,000