Sr. Quality Engineer in Manchester

Energy Jobline ZR; Manchester; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading medical device company in Manchester is looking for a Quality Engineer to support manufacturing quality operations. The role requires over 5 years of experience in medical device manufacturing, with a focus on compliance with applicable standards. You will lead investigations and validation activities while ensuring product specifications are met. The ideal candidate holds a Bachelor's degree in a related field and has strong project management skills.

Qualifications

• 5+ years of relevant experience in medical device manufacturing.
• Experience with standards like 21 CFR 820 and ISO 13485:2016.
• Knowledge of CAPAs and root cause analysis.

Responsibilities

• Ensure product compliance with specifications.
• Lead nonconformance reports and CAPA investigations.
• Conduct process validation activities.

Skills

Manufacturing experience

Quality Control

Project management

Statistical analysis (Minitab)

Leadership skills

Technical writing

Education

Bachelor’s degree in Manufacturing, Mechanical or related engineering

Tools

Microsoft Office (Word, Outlook, Excel)

Job description

COMPANY OVERVIEW

Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.

We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.

POSITION OVERVIEW

This position 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.

If you are interested in applying for this job please follow the application process. Energy Jobline wishes you the very best of luck in your next career move.