Quality Assurance Manager - $110K!

Regulatory/Quality Assurance Manager

A fast-growing medical device manufacturing company that has seen tremendous growth during the COVID-19 Pandemic, is seeking the right individual to join the Quality Control Team as the Regulatory Assurance Manager. The ideal person would possess strong written and oral communication skills and would have experience with Quality Systems such as cGMP/ISO14971/21 CFR 820 in a manufacturing environment.

Responsibilities

• Oversee the Quality Management System and continuous improvement for the medical device quality
• Provide Quality Assurance support for medical device projects, complaint investigations and design/change management
• Provide device design and development guidance and perform internal audits IAW 21 CFR 820
• Ensure risk management are developed IAW ISO 14971 and Medical Device and Combination Product procedures
• Liaise with external suppliers and participate in or lead investigations pertaining to quality and/or regulatory events

Requirements

• Bachelor's Degree in Chemistry, other Science or Engineering
• Knowledge of Quality Systems such as cGMP/ISO14971/21 CFR 820
• Independent problem solving/analytical skills/strong PC skills
• 5+ years' experience working in quality assurance in GMP, or medical device manufacturing

Benefits

• Medical/Dental/Vision/Life
• Two weeks of PTO
• 401(k) plan with up to 6% match
• FSA, HSA & wellness plan
• Relocation Assistance Available