Biomedical Quality Assurance Specialist

4 weeks ago

Clinton, Iowa, United States Haemonetics Full time
Job Summary:
Haemonetics is seeking a Quality Engineer to ensure that final medical devices, products, and manufacturing equipment meet defined requirements. The successful candidate will support the design of methods, systems, and processes to process or characterize blood components. They will perform testing and data analysis to assure that product or process requirements have been met. The Quality Engineer will 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, and Operations team to ensure that manufactured medical devices meet defined requirements.


Key Responsibilities:
Translate biomedical engineering requirements and design specifications into the Quality and Manufacturing space. Learn and apply standards, processes, policies, practices, techniques, and tools throughout the product/system lifecycle, including Standard Operating Procedures (SOPs) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems. Participate in the CAPA program and internal/external audits. Work under general supervision and apply knowledge of Biomedical/Chemical engineering methods and techniques, where work assignments require technical depth. Participate in and implement multiple improvement programs and follow up on the results achieved, for example, Quality KPIs, Production Efficiency, Document and Implement Approved Changes. Contribute to 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. Perform engineering and supplier quality project support, coordinating methods and processes, developing test protocols, performing routine testing and analyses, and writing technical reports. Solve problems using specialized engineering principles, tools, and methods to recognize and formulate problems, collect data through observation and experiment, and form, test, and validate hypotheses. Clearly document, communicate, and summarize technical findings and results for status updates, coordination, and recommendations. Proactively identify, communicate, and refer problems or coordination needs to supervisors; provide timely detailed background/data to support problem-resolution; seek guidance as necessary to respond to needs or changes, and quickly assess requirements to meet target milestones, goals, and deadlines. Take 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.

Requirements:
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. #LI-AR1

EEO Policy Statement

Haemonetics is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination against any applicant or employee based on any legally-recognized basis, including, but not limited to: race, color, religion, sex (including pregnancy, lactation, childbirth or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed service member status or any other status protected by federal, state or local law ("Protected Characteristic"). Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including managers and co-workers.

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