Our client, a medical device company in Offaly are currently looking to recruit a Quality Engineer for their site.
- You will have key responsibility for coordination of plant projects, sustaining materials, OPEX (Continuous improvement and costs reduction), Compliance and Quality related projects. Be the QA and Compliance subject matter expert on plant projects. Support and mentor project teams.
- You will be responsibility for the execution of assigned projects within cost and schedule requirements ensuring changes related to projects meet all regulatory and compliance requirements. Support process, product and software validation executions ensuring the validations meet the pre-determined acceptance criteria. Build robustness, capability and efficiency into process development.
- Manage corrective actions to assure effective corrective and preventative actions, to avoid repeat issues.
- Participate in our Risk Management program, identifying the true critical to quality procedures (CTQs) for each product code, quarterly updates to our risk management files.
- We are looking for a qualified person to third level degree in Engineering/Technical discipline and desirably with 3-5 years relevant quality engineering experience. You are a dynamic team player who can work effectively and proactively on cross-functional teams. Experience working in a quality engineering role with active involvement with the manufacturing floor. You will be competent in the use of Six Sigma and Lean Manufacturing Techniques. Proven experience in delivering projects from conception to completion, resulting in significant cost savings and process improvements. Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971). Ability to manage self and others to achieve challenging targets is advantageous. Risk management training to ISO14971:2012 is desirable. You are innovative, proactive, and organised with excellent attention to detail and quality awareness. Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance. You are a good communicator and fluent in English, both in writing and speaking.
- Leadership Expectations provide the framework for what we expect from all employees at the company - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
- We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
- Demonstrates Global Business Acumen
- Thinks Critically and Makes Sound Decisions
- Sets Strategic Direction
- We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
- Collaborates and Creates Alignment
- Attracts, Deploys, and Develops Talent
- Fosters Diversity and Inclusion
- We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
- Focuses on Patient and Customer
- Generates Breakthrough Ideas
- Initiates and Leads Change
- We do what we say we are going to do, delivering results with the highest standards.
- Sets High Standards
- Instils Operational Excellence
- Drives Accountability
- Models Ethical Behaviour
For further information on this Quality Engineer role in Offaly please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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