Senior Quality Engineer

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.