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Quality Investigations Engineer - Medical Devices

Oxfordshire   •  Negotiable  •  Permanent, Full time

Medical Device Product Quality Investigation Engineers I need to speak to you about an opportunity I am recruiting for to join my client who are looking to invest in an enthusiastic Quality Customer Investigations Coordinator. Could this be your next role?

As the Quality Professional you will be the go-to person for all quality related concerns or issues. This role will be the main point of contact for our clients key customers and you will liaise directly with the production team to challenge, raise and drive change within the process, ensuring our client remains compliant and adhere to regulatory standards.

The Key Responsibilities of the Quality Customer Investigations Engineer will be as follows..

Maintain trusted relationships with our customers and manage all quality related queries

Drive and improve compliance adherence within the business documented Quality System and requirements of ISO 13485, CFR 820, CMD/CAS, Directive 43/92 EEC, Medical Device requirements and EU GMP

Ensure prompt investigation and resolution of quality issues, writing detailed investigation reports

Manage and host customer visits and deliver key information as requested by the customer

Liaise with customers to drive appropriate metrics, monitor data gathering and prepare reports for customer to meet required frequency

Work with other areas within QA (e.g. Labs) and across the business (e.g. Moulding, Assembly, Warehouse) to support improvements

To be successful in this role, you will need:

Knowledge of Lean Manufacturing Principles

Knowledge of the requirement of ISO 13485, GMP, cGMP, CFR 820

Experience of managing continuous improvement projects within medical device manufacturing

Recent experience of working within a quality environment

Excellent communication and relationship building skills

Audit experience

Excellent presentation skills

To be hands on and able to work both independently and as part of a team

To be process driven, able to clearly document and report on changes to the process

What you will receive in return?

You will be joining a successful, privately owned industry leader who are constantly innovating and looking to improve lives, empower patients and relieve the pressure on healthcare professionals. We invest heavily in our staff and offer a competitive salary and benefits package along with the opportunity to develop within the business. Additional benefits include:

Remote working up to 2 days per week

Flexi time covering 37.5 hours per week with core working hours of 9:30am-12 Noon and 2:00pm-4:00pm (3:30pm on Fridays)

25 days annual leave (with the opportunity to earn loyalty days with length of service)

Holiday purchase scheme (up to 10 days purchased per holiday year)

Enhanced Family Friendly Policies

Enhanced Sickness Pay

Group Life Insurance

Wellbeing initiatives and support

Annual company bonus

Free parking, free tea & coffee and free fruit

  • Agency: Cpl Life Sciences
  • Reference: JO-2207-497535
  • Posted: 22nd July 2022
  • Expires: 19th August 2022

Cpl Life Sciences

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