Senior Quality Engineer Merrimack Manufacturing - 2.3 Manchester, NH Job Details Full-time 5 hours ago Qualifications Customer communication Microsoft Excel Microsoft Outlook Accreditation standards (regulatory compliance area) Project management experience in technology ISO standards Project management experience in manufacturing Manufacturing facility experience Task prioritization Internal compliance assessments Regulatory/legal compliance standards in production Biomedical regulatory compliance Compliance standards auditing FDA regulations Data analysis software Full Job Description

COMPANY OVERVIEW

Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.

POSITION OVERVIEW

This positon will support manufacturing quality operations in a dynamic, fast-paced, medical device-manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.

RESPONSIBILITIES

Working under the direction of the Quality Manager, ensure all product, processes, and components are within specifications. This position may also serve as a member on collaborative cross-functional teams, to support new product development efforts, commercial production, material-related design changes, and manufacturing and process changes, risk management activities, and other compliance projects. Work in compliance with applicable standards and regulations such as 21 CFR 820 and

ISO 13485

2016. Lead the Device History Records (DHR) review and approval process. Lead nonconformance reports (NCR) and CAPA investigations. Lead the development and implementation of PFMEAs and control plans. Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV). Lead manufacturing and quality system improvements. Lead customer feedback process and investigations. Author Engineering Change Orders (CO); support CO implementation tasks Use experience with engineering and technology to ensure compliance with applicable standards and regulations. Position requires daily contact with members of Production, Engineering, Materials, and Quality departments. Routine contact with design authority and customers; occasional contact with auditors

QUALIFICATIONS AND SKILLS

5+ years of experience related to the manufacturing of medical devices in a QMS environment while being in a Quality Control or Engineering role Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and

ISO 13485

2016 is required Experience with Microsoft Office software (Word, Outlook, Excel) required Experience participating in internal and external audits Strong project management, prioritization and leadership skills are required Must be able to manage multiple priorities Performing statistical data analysis using Minitab or equivalent Presenting and leading meetings with an audience of peers and senior management level Use critical thinking and deductive reasoning to make risk based decisions Knowledge and comprehensive understanding of CAPAs, root cause analysis, and the 8D method Excellent oral communication and technical writing skills High level of attention to detail and accuracy

EDUCATION

Bachelor's degree or equivalent experience in Manufacturing, Mechanical or related engineering / life sciences related discipline. bArpl0osO5