Quality Engineering Team Lead

Job description

Medical Devices

Permanent

Ireland

€60,000 - €75,000

Quality Engineering Team Lead

An Extraordinary role on offer as a Quality Team Lead within Engineering with one of the global leaders in medical technologies, alongside the opportunity to have a hand in the continual growth through a wide array of diversified innovative products and services.

Have you worked within Quality Team Engineering Lead in relation to Medical Devices? Would you like to be a part of the continual improvement of systems and innovation of Medical Devices to benefit all? Are you looking for a role that recognises your expertise as well as your part of playing an instrumental role in the success of a company?

We are currently seeking a Quality Engineering Team Lead to join our Medical division to be based in The west of Ireland, this role will be responsible for undertaking management efforts for the Research & Development projects through management of teams, creating and design development of products and systems.

Responsibilities

Responsibilities within the role consist of various upkeeping of quality standards within the engineering team.

Responsibility for day to day workload and operational issues of the quality engineering team. This includes, setting up team and individual objectives , whilst carrying out performance based appraisals, generating plans for training and dealing with issues in relation to performance.

A need for direction and logistical support to the QE team members to ensure completion within the team to meet set timelines, whilst providing leadership and being a mentor to team members to again ensure efficient completion, with a responsibility for implementing requirements in accordance with relevant medical device standards such as ISO13485.

Proactive viewpoint for ways in which to improve the function of the Quality Engineering Department, whilst driving all assigned Quality Engineering projects and ensuring that they are structured and managed within compliance with the relevant procedures.

Be the representative of the team at key review meetings, with a need to work closely to build effective relationships with other functions within the business. With an emphasis on promoting awareness of best industry practice and making appropriate decisions daily, whilst reporting to the Quality management.

Ensure that external & internal Quality issues are effectively prioritised and acted upon in a efficient & timely manner, whilst being responsible for Quality systems including multiple key processes within the Quality Engineering group, such as Supplier Quality, Complaint Investigations, Corrective Action Preventive Action (CAPA)/ Supplier Corrective Action ( SCA) ,Non Conformances (NCR), Statistical Analysis, Health Risk Assessment &Field Action.

Key Support of the Supplier Audit, Internal Audit and Regulatory Audit Programmes, whilst preparing the execution and analysis of Quality Engineering Documentation. Full awareness of trending and analysis of key metrics within quality, delegating for the Quality Engineering Manager whilst doing so.

Profile

Third level qualification in Engineering, Science or any relevant technical discipline.
Proven experience and knowledge, with a preference of 6 years experience as a minimum with the likes of ISO13485, ISO14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, preferably gained within the medical device industry.
Ideally having Supervisory experience previously.
Experience with combination devices would be ideal, with sterilisation and/or microbiology would be advantageous.
Proven track record of a pursuit within self-improvement,
Good working knowledge and understanding of statistics
Experience and knowledge of all aspects of within validation, including design, software, process, and cleaning.
Strong attention to detail.
Experience and willing self-starter
Availability and willingness to travel on company business.

What next?

If this role is desirable to you then you can get in touch and apply here.

My Email: (url removed)

Number: (phone number removed)

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients