Quality Engineer - Spark Life Solutions Inc

Roles & Responsibilities:

• Ensure the Quality Management System (QMS) is established in accordance with ISO 13485:2016 and 21 CFR 820 and fit for ISO/MDSAP certification.
• Collaborate with representatives from various functional groups, including engineering, purchasing, and production/manufacturing.
• Ensure customer and division quality requirements are met by working closely with teams of engineers and product specialists.
• Collaborate with Product Development, Operations, and Manufacturing to provide guidance as it relates to the continuous improvement of the quality system and to ensure compliance with the product, clients, and regulatory requirements
• Provide guidance to Lumos team members undertaking Design Control and Risk Management activities to ensure compliance with regulatory requirements
• Facilitate risk management activities for products throughout the device lifecycle per company procedure and ISO 14971
• Assure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
• Create, document, and implement inspection and testing acceptance criteria and procedures from to ensure adherence to established quality standards to ensure high productivity and high technical integrity.
• Review design, manufacturing, and testing documentation.
• Provide leadership in root cause failure investigations, product stability evaluations, product release, nonconforming material, supplier quality, metrology, and new product introductions.
• Conduct root cause analysis, propose and implement corrective and preventive actions (CAPA), and work on improving product and process quality.
• Liaise between Quality Assurance and Quality Control to ensure cohesive quality strategies.
• Identify and drive continuous improvement initiatives of procedures, methods, tools, techniques, training, etc., to enhance project and process specific efficiency, in conjunction with stakeholders within the business, to ensure that QMS and Regulatory processes meet the needs of the company, regulatory bodies, and applicable standards.
• Offer technical guidance and support in response to quality testing and analysis.
• Develop and analyze statistical data and product specifications to determine standards and establish the quality and reliability expectancy of finished products.
• Write, edit, and approve QC investigation reports.
• Present failure investigation findings to peers and management.
• Perform statistical analysis of data from experiments and manufacturing process trend monitoring.
• Support Receiving/Inspection functions by creating and reviewing raw material specifications.
• Project manage post-market surveillance activities.
• Oversee inspection activities for the product throughout the production cycle.
• Formulate, document, and maintain quality control standards and ongoing quality control objectives.
• Review and approve Contractor and sub-contractor quality control documentation to ensure their planned activities meet contractual requirements.
• Ensure a high level of internal and external customer service. Oversee complaint handling process and work with the appropriate function(s) to investigate and resolve customer issues and complaints.
• Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project-specific plans.
• Perform other related duties as assigned by management.

Education & Experience:

• 5+ years in manufacturing functions within an engineering discipline.
• Bachelor's degree in engineering or a related field.
• Experience in new product development and introduction to manufacturing.
• Experience in risk management and post-market surveillance.
• Interaction with regulatory bodies (FDA ISO).
• Medical device manufacturing experience is required.