Location: Plymouth, MN
Description: Our client is currently seeking a Senior Quality Engineer. Below are the details:
Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
Position Summary: Provide support and direction for the implementation of quality systems associated with New Product Development projects for the Research, Development and Introduction of new Products, Processes and Technologies.
Will work within the new product development team, with responsibilities including, but not limited to the following:
• Guide NPI teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies. Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
• Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
• Involved in developing, modifying, and executing design controls per company guidelines and procedures.
• Provide input throughout the new product development process from a quality perspective
• Lead risk management for project including risk analysis and development of sound mitigation strategies
• Lead efforts for usability and human factors engineering
• Collaborate with Design Engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
• Support process and product validation programs for new product development
• Educate NPI team on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
• May perform supplier development activities surrounding PPAP
• Develop and create procedures for incoming, in-process and final inspection of components and finished goods
• May have involvement in continuous improvement projects for the organization
• Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.
• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent discipline is required.
• A minimum of 2-3 years experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment
• A minimum of three years' experience as an AQE or Design Quality Engineer preferred
• Previous experience in a regulated environment preferred
• ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable
• Knowledge or certification in GD&T preferred
• Proficient understanding of Med Device manufacturing processes
• Familiarity with ISO 13485, GDP, GMP, MDR.
• Excellent communication skills and attention to detail
• Has a strong understanding of engineering and quality practices & methods
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, PowerPoint and One Note.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Working knowledge/experience of statistical techniques
• Knowledge in reliability engineering practices preferred
• Highly developed problem solving and strong analytical skills
• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
• Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.
• Manages change well and adopts a continuous improvement orientation to the role
• Ability to be the voice of Quality when dealing cross functionally. Will take the lead in discussions / meetings to ensure the correct outcome.
Posted 7 minutes ago
Posted 7 minutes ago
Posted 7 minutes ago