Merrimack Manufacturing

Merrimack Manufacturing, a medical device manufacturer in Manchester, NH, seeks a professional to support design transfer activities and quality operations. This role involves generating and maintaining QMS documentation, leading improvement projects, and ensuring compliance with regulatory standards. The ideal candidate will leverage engineering and technical expertise to evaluate new products and processes, contributing to the organization's goals and bringing innovative products to life.

Requirements

• At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry
• Strong knowledge of CFR Part 820 and ISO 13485
• Lean or Six Sigma certification preferred
• Strong knowledge of IQ/OQ/PQ requirements
• Knowledge of Design Transfer and introduction of new product processes
• Strong knowledge of tolerance stack up calculations and calibration best practices
• Strong organization, communication, and time management skills
• Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred