Cache of job #14041102

Job Title

Quality Engineer Wexford

Employer

FRS Recruitment

Location

Wexford

Description

Amazing Quality Engineering opportunity to join a world renowned Medical Device organization in the Sunny South East of Ireland! * Quality Engineer * Wexford * Medical Device Expansion Our Client is currently growing their Quality team and have a number of new exciting products being introduced to the site this year. They are looking for a dynamic Quality Engineer who will be dedicated to quality system development, and advancement ensuring greater compliance across the facility. They will play a key role in the development and execution of plans to ensure compliance to the new MDR regulations and also ensure systems developed will allow for continued compliance to standards as they are revised. This role requires a high level of ownership and enthusiasm. What is in it for you? Attractive salary and benefits package on offer together with a friendly, welcoming and collaborative working environment. This is great opportunity to expand your skillset in this fast moving, dynamic and agile business.You will get exposure to a lot of different areas and departments working cross functionally. Days role, flexitime available & half day on a Friday! Onsite parking and canteen. Commutable distance from Kilkenny, Waterford, Tipperary or Wicklow. Key Responsibilities: Works within the Quality Operations Group to support manufacturing and provide decisive, scientifically based solutions to process problems and to support process improvement. Utilizes quality engineering methods to ensure that the product design is transferred into manufacturing processes that are capable of reliably delivering products that are safe and effective and consistently meet the performance requirements. Applies quality engineering principles and techniques to ensure that the products developed and manufactured by the division meet or exceed performance specifications and regulatory standards. Ensures that the division complies with all applicable procedures, regulations and standards during the development and manufacture of its medical device products. Applies risk management, change control and validation principles and techniques throughout the product lifecycle (from development over design transfer to manufacture and distribution. Participates in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non conformances so that issues are resolved to close out with no recurrences. Provides Quality Engineering representation on cross-functional product development teams. Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance. Leads cross-functional teams to develop risk assessments and risk controls. Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods. Key Requirements: Relevant Degree Qualification in Science/Engineering/Technical. Minimum of 2 years in a similar QE role within a highly regulated industry with good working knowledge of regulatory requirements and Quality Systems techniques. Knowledge of quality management systems ISO 13485, GMP. Experience in risk-based decision making and problem-solving. Knowledge of design validation, design transfer and change control principles and techniques. Knowledge of statistical methods and Six Sigma process excellence tools. Knowledge of risk management principles and techniques. Knowledge of supplier qualification and management principles and techniques (incl. auditing techniques. Knowledge of project management fundamentals and tools. Excellent interpersonal skills with the ability to work as part of a team and and on own initiative. Proven ability to problem solve and work to targets with excellent organisational skills, attention to detail and adaptability. Next Steps: Click Apply! For more information and to review the FULL JOB SPEC please email your CV. I would be delighted to speak with you and guide you through the whole process! This job originally appeared on RecruitIreland.com.

Date Added

1724 days ago

Apply