Quality Engineer - Brasseler

Job Overview

This position is responsible for developing and implementing systems to ensure products and/or services are designed 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 also participates 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.

• Engage in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes.
• Provide ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.
• Drive supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis.
• Partner with key suppliers and manufacturing personnel to reduce defects and improve yield.
• Participate in supplier selection and qualification processes.
• Conduct periodic trend analysis and provide business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions.
• Implement problem solving methodologies to reduce internal and external defects.
• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects.
• Validate key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation.
• Identify and implement product and process controls consistent with the outcome of the risk management process.
• Author validation, verification and inspection assessments to ensure product test and manufacturing data support product release.
• Select appropriate tests and sampling sizes based on critical abiland statistical calculations.
• Maintain knowledge of relevant quality and regulatory standards and augment quality system processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others.
• Conduct computer system validation and stay current with validation regulatory requirements.
• Participate in special projects and perform other duties as required.

• 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.

• Bachelor’s Degree in engineering, typically electrical or mechanical.
• Master’s degree in engineering, an MBA or global equivalent – plus.
• ASQ Certification – plus.

• Experience in product engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry.
• 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.
• Understanding of and ability to act on financial information that contributes to business profitability.
• 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.
• Effective communication with senior management.
• Good negotiating skills and ability to manage outsourced relationships.

• Strong working knowledge of medical device regulations including 21
  
  CFR
  820, MDD, MDR and other global regulatory requirements and quality system standards such as ISO
  14971, IEC 60601.
• Demonstrated success in the implementation of problem solving methods…