Senior Quality Engineer

Merrimack Manufacturing; Manchester (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a qualified professional to support manufacturing quality operations in a fast-paced, regulated environment, including design verification, design validation, and commercial production.

You will lead the Device History Records reviews, NCR and CAPA investigations, PFMEA and control plans, and IQ/OQ/PV activities, coordinating with Production, Engineering, Materials and Quality to ensure 21 CFR 820 and ISO

Qualifications

• 5+ years of experience in medical device manufacturing within a QMS environment (QC or Engineering).
• Experience with 21 CFR 820 and ISO 13485:2016 compliance.
• Experience with internal and external audits.
• Strong project management and leadership skills.
• Knowledge of CAPA, root cause analysis, and 8D problem solving.
• Excellent written and verbal communication.
• Detail-oriented with high accuracy.

Responsibilities

• Lead device history records (DHR) review and approval.
• Lead NCR and CAPA investigations.
• Develop PFMEAs and control plans.
• Lead IQ, OQ, PQ/PV, TMV validation activities.
• Drive manufacturing and quality system improvements.
• Coordinate with cross-functional teams on design changes and risk management.
• Facilitate customer feedback investigations and audits.

Skills

Quality management

Regulatory compliance

Project management

Audits

Data analysis

Education

Bachelor's degree in Manufacturing/Mechanical or life sciences

Tools

Microsoft Office

Minitab

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.