Sr. Quality Engineer
65 Pitts Station Road Marion, NC 28752 US
Provide Quality 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 Strong communication skills 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 year 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.
Target pay: 50-55/hr
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