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.
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* 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.
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* PREFERRED EDUCATION:

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* ** 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 21

CFR
820, MDD, MDR   and other global regulatory requirements and quality system standards including ISO
14971, 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 pounds

Over  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 Great Depression, 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…