Quality Engineer - Brasseler

This position is responsible for developing and implementing systems to ensure products and/or services are design and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required.This role will also participate in the implementation of the company’s quality system processes related to complaint handling, process validation, internal nonconformities, product development and supplier quality to provide engineering analysis and support in verification, validation and problem solving. **KEY RESPONSIBILITIES:** Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes.Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations. Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements.Implements problem solving methodologies to reduce internal and external defects. Provide quality engineering insight and guidance on product development, product improvement and process improvement projects.Validates key design inputs including usability, reliability, performance, ability to manufacturer, safety and effectiveness. Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others as required. Conduct computer system validation and stay current with validation regulatory requirements. Participates in special projects and perform other duties as required. **MINIMUM WORK EXPERIENCE:** 3 or more years of engineering experience, ideally within the medical device industry, including roles within product development or manufacturing engineering.Experience in a disciplined engineering environment.**PREFERRED EDUCATION:** **GENERAL SKILLS & COMPETENCIES:** Previous experience in product engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry. A working knowledge of LEAN and Six Sigma concepts and tools. Outstanding verbal and written communication skills Excellent presentation and public speaking skills Excellent independent decision making, analysis and problem solving skills Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility Excellent planning and organizational skills and techniques Good negotiating skills and ability to effectively manage outsourced relationships **SPECIFIC KNOWLEDGE & SKILLS:** Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards. Experience in product verification/validation, process validation and test system development and implementation. Experience in the development and implementation of processes and Practical experience with the implementation of statistical tools and techniques. General knowledgeable in computer system validation and related regulatory requirements While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 poundsOver Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the GreatDepression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners. Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company. Now serving more than 1 million customers in 33 countries andterritories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our as our founders would have wanted. We live those values by ensuring that our culture focuses on the of our team, which we accomplish by providing a for individuals to develop and contribute authentically, with opportunities to and the communities where we live and work. No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of , as a result of a physical or mental impairment, you can request reasonable accommodations.Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.US Candidates: View email address on click.appcast.io UK and Ireland Candidates: View email address on click.appcast.io and New Zealand Candidates: View email address on click.appcast.io Candidates: View email address on click.appcast.io Candidates: View email address on click.appcast.io### Workplace Remote TypesIt is important to us to offer different types of work arrangements. Please see the types we offer below: #J-18808-Ljbffr Brasseler USA Inc.