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Quality Engineer - Medical Devices

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Wolverhampton

On-site

GBP 35,000 - 55,000

Yesterday
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Job summary

An innovative medical devices company is seeking a Quality Engineer to ensure product quality and compliance with design specifications. This role offers the chance to work closely with a dedicated production team, overseeing supplier quality assessments and maintaining Device History Records. The ideal candidate will have experience in the medical devices sector, particularly with ISO 13485 and 14971 standards. Enjoy a competitive salary, excellent benefits, and opportunities for career progression in a fully onsite position. Join a team where your contributions will directly impact the quality of life-enhancing products.

Qualifications

  • Prior experience in medical devices, especially with ISO standards.
  • Knowledge of quality control processes in manufacturing.

Responsibilities

  • Conduct incoming inspections of parts and manage customer returns.
  • Ensure compliance with document control, CAPA, and complaints processes.

Skills

Medical Devices Experience

Quality Control

Production Knowledge

ISO 13485 Standards

ISO 14971 Standards

Job description

Job Description

Quality Engineer - Medical Devices

Newton Colmore is working with a medical devices company in the West Midlands, and we are assisting them with their search for a key Quality Engineer hire.

The role as Quality Engineer will give you the opportunity to work on market leading medical devices whilst working closely with the production team to ensure that the parts delivered from the company's suppliers meet the design specifications and quality requirements. The quality engineer will help the production team in supplier quality assessments including creating and following up on SCARs and will also ensure that the Device History Record (DHR) is up to date for products manufactured. This is a key new role within the team, and you will be reporting directly to the head of the team, and collaborating with the five members of the production team.

This role will also cover key responsibilities such as:

  1. Incoming inspection of parts
  2. Customer returns
  3. Ensuring that document control, CAPA, and the complaints process is followed effectively

To be considered for the Quality Engineer role you will need to have prior medical devices experience, ideally to both 13485 and 14971 ISO standards. This will be paired with quality control and production knowledge within a manufacturing environment.

In return for your hard work, the company offers a highly competitive salary and benefits package as well as providing excellent career progression opportunities and hands-on training. Because of how closely you will be working with the production team, this will be a fully onsite role.

In regard to the process, there is a two-stage interview process where you will be invited to showcase your skills and experience, while finding out more about the company, their mission, and what they can offer you.

To enter the recruitment process, click apply now and if you have the right skills and expertise, I will be in touch to discuss the opportunity further.

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