Merrimack Manufacturing
Merrimack Manufacturing represents a unique culture which fosters a fast-paced multidisciplinary and inventive environment$1. .$1
51 - 200
Jr. NPI Quality Engineer
August 26
🏢 In-office - Manchester
Merrimack Manufacturing
Merrimack Manufacturing represents a unique culture which fosters a fast-paced multidisciplinary and inventive environment$1. .$1
51 - 200
Description
• Support design transfer activities and quality operations in medical device-manufacturing environment • Generate and maintain control plans, risk management files, validation protocols, and other QMS documentation • Lead investigations resulting in root cause and corrective actions • Develop inspection procedures and sampling plans for new production, continuous improvement of process controls • Participate in Material Review Board (MRB) meetings, track and follow through with nonconformance reports assigned • Contribute towards the success of external audits
Requirements
• Candidate must have a B.A. or B.S. degree; equivalent experience in relevant technical fields will be considered • At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry such as Aerospace, Military, etc. • Strong knowledge of CFR Part 820 and ISO 13485 required • Lean and Six Sigma certification strongly preferred • Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications • Knowledge of New Product Introduction processes and deliverables • Strong knowledge of tolerance stack up calculations and calibration best practices • Strong organization, communication, and time management skills; Project Management experience preferred • Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred
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