QA Engineer II, Biomedical

Haemonetics - Clinton, PA

Full-time - Entry Level

Clinton, PA

Plastics and Rubber Products Manufacturing

About the position

The Quality Engineer role at Haemonetics is responsible for ensuring that final medical devices, products, and manufacturing equipment meet defined requirements. This position involves supporting the design of methods, systems, and processes for processing or characterizing blood components, performing testing and data analysis, and collaborating with various business units to address design and manufacturing issues before product release.

Responsibilities

• Ensure final medical devices and products meet defined requirements.
• Support the design of methods, systems, and processes for blood component processing.
• Perform testing and data analysis to assure product and process requirements are met.
• Create and review documentation for product design control and market release.
• Work cross-functionally with R&D, Manufacturing Engineering, and Operations teams.
• Participate in the CAPA program and internal/external audits.
• Contribute to design reviews of new or modified products.
• Develop test protocols and perform routine testing and analyses.
• Document and communicate technical findings and results clearly.
• Identify and refer problems or coordination needs to supervisors.

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.
• Experience with data analysis or statistical process controls using Minitab, Tableau, Excel (advanced), etc.
• Experience with document management systems such as Agile, SharePoint, DocuWare.

Nice-to-haves

• Master's degree in Engineering or Science with 1+ year of working experience in the life science field.

Benefits

• Professional growth and development opportunities.
• Dynamic and exciting work environment.