Quality Engineer - Katalyst Healthcares & Life Sciences

• IV solution/bag experience.

• Manufacturing experience.

• Validation of equipment .

• Provide Quality a Engineering support to manufacturing and product development teams for mechanical devices.

• implement quality improvement projects and participate in quality activities and support a factory-focus team for a production line.

• Provide support for released products, evaluate field returns, and support the incoming inspection department and in-process inspections where required.

• Perform component qualifications and validations to support key development and continuous engineering projects.

• Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member.

• Perform return product investigations for product complaints.

• Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines.

• Perform key deliverables in support of development and continuous engineering R&D projects, which include Mold tool qualifications, component qualifications, design and product risk assessments, shelf-life validations, and sterilization validations.

• Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation for new products.

• Set inspection requirements, set inspection methods and inspection sampling plans.

• Support quality control inspectors with new product inspections and quality issues that arise during inspections.

• Support and test component changes to current products.

• Support internal audits and supplier audits.

• Self-motivated worker.

Requirements:

• Working knowledge and understanding of mechanical drawings.

• Strong problem solving, technical writing, and statistical analysis skills.

• Preferred experience with supporting a manufacturing product line.

• B.S. degree in Engineering.

• 3-5 years in an engineering role within a Medical Device company, 2 years minimum in Quality Engineering function. Must have working experience of GMP and ISO 13485 requirements.

• Sitting/standing 8 hours per day. Light lifting may be required on occasion.

• Ability to work under a microscope.

• Ability to be in a clean room environment with varying humidity levels Ability to travel occasionally.