QA ENGINEER II, BIOMEDICAL

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Job Details

Job Summary:

This role is responsible for ensuring that final medical devices, products, and manufacturing equipment meet defined requirements. The Quality Engineer will support the design of methods, systems, and processes to process, or characterize blood components.  Performs testing and data analysis (statistical process control) to assure that the product or process requirements have been met. Create and review documentation to support product design control, manufacturing, and market release.  This role requires working with other business units to identify design-for-manufacturability and end of line functional testing issues, ensuring these issues are addressed prior to release.  Works cross-functionally with the R&D, Manufacturing Engineering, & Operations team to ensure that the manufactured medical devices meet defined requirements.

Job Description:

• Translate biomedical engineering requirements, and design specifications into the Quality & Manufacturing space.

• Learns and applies standards, processes, policies, practices, techniques, and tools throughout the product/system lifecycle including Standard Operating Procedures (SOP’s) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.

• Participate in the CAPA program & Internal / External Audits

• Works under general supervision and applies knowledge of Biomedical / Chemical engineering methods and techniques, where work assignments require technical depth.

• Participate in and implementing multiple improvement programs and following-up on the results achieved, for example; Quality KPIs, Production Efficiency, Document and Implement Approved Changes.

• Contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.

• Performs engineering and supplier quality project support, coordinating methods and processes, developing test protocols, performing routine testing and analyses, and writes technical reports.

• Knowledge of business fundamentals, and leverages creative skills with understanding of policies, procedures, and product/project and operational goals and priorities by executing assigned work with quality, accuracy, and timeliness.

• Solves problems using specialized engineering principles, tools, and methods to recognize and formulate problems, collect data through observation and experiment, and forms, tests, and validates hypotheses; Clearly documents, communicates, and summarizes technical findings and results for status updates, coordination, and recommendations.

• Good working knowledge of project management practices and communicates proactively, openly, and cooperatively within/across department(s) and with supervisory staff to keep team informed; provides oral reports, and prepares timely and clearly written status reports, updates, and technical presentations.

• Learns/develops diversity/global awareness and communicates with cultural sensitivity.

• Proactively identifies, communicates, and refers problems or coordination needs to supervisors; provides timely detailed background/data to support problem-resolution; seeks guidance as necessary to respond to needs or changes, and quickly assesses requirements to meet target milestones, goals, and deadlines. Takes initiative to offer suggestions for improved methods, processes, products, services, or techniques.

• Comply with all ISO 14001 requirements.

• Comply with internal environmental management system requirements, as applicable.

Required Qualifications:

• Bachelor's Degree in Engineering, Science, or related field.

• 2-5+ years of working experience in a quality related job function .

• Professional experience with product development or manufacturing under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.

• Professional experience with data analysis or statistical process controls utilizing programs such as Minitab, Tableau, Excel (advanced), etc.

• Professional experience with a document management system such as agile, SharePoint, DocuWare, etc.

• In lieu of product development and manufacturing, candidates with extensive experience performing testing and data analysis in a diagnostic laboratory may be considered.

• In lieu of 2+ years of working experience, candidates with a Master’s degree in Engineering or Science, and 1+year of working experience in the life science field may be considered.

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