Quality Manager

Location: Noblesville, IN, 46060

Quality Manager - Medical Device

Nexxt Spine LLC., one of the best-positioned companies in the medical device industry, seeks a Quality Manager to add to our dynamic team.  Located in Noblesville, Nexxt Spine designs, manufactures, and distributes a rapidly expanding line of spinal products

SUMMARY

Focus on management of quality systems and personnel, as well as utilizing best Quality practices for the effective and efficient development, transfer, and maintenance of products and processes throughout the product lifecycle.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Implement FDA guidelines for cGMP & ISO 13485
• Maintain calibrations and gaging system
• Collaborate with Engineering to establish product control plans and inspection documents.
• Internal auditing company-wide for adherence to SOPs
• Supplier evaluation, auditing, and monitoring
• Management of Non-conforming Material Reporting system
• Management of Receiving Inspection of raw materials and purchased products
• Perform IQOQPQs for equipment and processes
• Oversee manufacturing Quality personnel
• Quality trending and reporting quarterly management reviews
• Implement continuous improvement using statistically validated processes
• Ensure adherence to the Quality Manual
• Various other tasks relevant to a growing business

QUALIFICATIONS 

• Must be well-versed in ISO 13485.
• Must be self-motivated to produce high-quality parts.
• Must be able to effectively communicate at all levels.

EDUCATION and/or EXPERIENCE        

Four-year college degree from an accredited university in a related field.  Experience in an FDA-regulated manufacturing environment is preferred.

Nexxt Spine LLC is an equal-opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits, and opportunities for professional growth.