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Job ID: JOB-13482

Senior Quality Systems Engineer

We are speaking with experienced Quality Systems Engineer about the exciting new job opportunities in the well-loved city of Galway!  Our leading client is currently hiring for their team of Quality Systems Engineers . Are you considering a career move? 

This job opportunity with our client could stand out due to their great culture, exceptional career development pathways along with their unrivalled rewards and recognition packages.

This exciting new job opportunity in Quality systems Engineer is located Galway, voted “Europe most Friendliest City 2020”!

Apply now to find out more.

Purpose

The position requires an experienced and proven candidate with a background in Development and Maintenance of Quality Systems, Quality Engineering (including Design Control). The successful candidate will work as part of a team to maintain high quality/performance standards across the company.

Reporting to the Quality System Supervisor, the position will be challenging and will require an ability to work autonomously.

Roles & Responsibilities

• Work with Key Stakeholders to lean the current QMS to achieve an efficient QMS.
• Work with Site Integration project team to implement standardised corporate procedures and work instructions in line with project timelines.
• Support on-going maintenance and introduction of new and or revised corporate standardised procedures and systems.
• Become proficient in electronic systems used to support the QMS and function as a local site SME and administrator.
• Work closely with the notified body to successfully obtain ISO13485 certification for additional company locations.
• Ensure that the necessary updates are communicated to the regulatory bodies and customers as changes arise.
• Work with Regulatory Affairs to provide documentation to external customers to support their submissions
• Support Notified Body / Regulatory Agency / Customer Audits
• Perform Internal and Supplier Audits
• Actively support creation of Internal, Supplier and Customer Audit Program
• Actively support Supplier Management Process Program
• Manage the tracking of the Corrective / Preventive Management Process, working closely to support CAPA leads to successfully implement effective CAPA.
• As required take leadership on the execution of Quality System related CAPAs.
• As required act as an Independent Quality approver on Quality System related CAPAs.
• Manage the tracking of the Complaint Handling Process, working closely with Quality Engineers and key stakeholders to ensure timely closure of complaints / manufacturing investigations.
• Actively participate in the Documentation control process
• Work with ECN Owners and Doc Control personnel to schedule processing of Engineering Change Orders
• Develop and maintain documentation in compliance with relevant requirements.
• Initiate / Approve Engineering Change notices.
• Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
• Collate and trend Key performance indicator data.
• Actively participate in Management Review & Compliance meetings
• Provide Leadership, coaching and guidance to department Technicians and Quality Engineers
• Act as delegate for Quality System Supervisor when required.
• Performs other related duties, as assigned.

Role Requirements

• Minimum of degree level 8 in manufacturing engineering, quality engineering, life science or related field
• Minimum of 6 yrs. experience within the Medical Device Industry with proven ability of acting at a senior engineer level.
• Proven record in the Development and Maintenance of Quality Systems, Quality Engineering (including Design Control).
• Lead Auditor Training / Certification would be an advantage.
• Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team, with record of delivering on tight deadlines
• Experience of using Lean Manufacturing Tools and Techniques an advantage

For further information on this role in Galway please contact Aisling Kidney on 0872197421 or careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Aisling Kidney

JOB-13482

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