Kelly Services are recruiting for a Quality Engineer for a re-branding project for a County Offaly based medical device company.
Based in their Manufacturing facility in Tullamore, Co Offaly, and reporting to the Engineering and Validation Supervisor, you will be part of dynamic project teams chartered with the delivering on key plant projects. The team is accountable for following the companies Project Management process to drive highly disciplined project execution to meet all safety, quality, service, delivery and cost requirements.
You will have key Quality responsibilities on assigned business, new product introductions, sustaining materials, OPEX (Continuous improvement & cost reduction), Compliance and Quality related projects. You are expected to be the Quality and Compliance subject matter expert on assigned projects which may include but not limited to risk management, quality control documentation, production process controls and documentation review .
You will be responsible, as part of the project team for :
- 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 validations meet pre-determined acceptance criteria. You will manage corrective actions to assure effective corrective and preventative actions to avoid repeat issues.
- Participate in the company's risk management program, identifying the true critical to quality characteristics (CTQs) for each product code, quarterly updates to our risk management files.
KEY RESULT AREAS / KEY TASKS
Responsibilities will include, but are not limited to, the following:
- Support projects and initiatives across the plant where required, ensuring key deliverables are achieved in a timely manner and liaising effectively with internal and external customers
- The ongoing drive to improve overall site quality performance by use of root cause analysis tools and techniques, with a specific focus on customer complaint reduction
- Manage corrective actions to assure effective corrective and preventative actions to avoid repeat issues
- Participate in our Risk Management program, identifying the critical to quality characteristics (CTQs) for each product code, quarterly updates to our risk management file
- Conduct product training, to build understanding of quality requirements in all levels of the organization through training and coaching activities
- Conduct internal audits and support site during internal and external audits. Actively participate in and support company and plant wide initiatives including six-sigma, lean, safety and cost reduction
- Support reporting methodologies for CPK, PPK metrics for the top product codes at the plant. This may include the implementation of SPC.
- Complete all identified training and development activities as required including allocated MyLearning courses.
- Adhere strictly to company policies, procedures and plant key behaviours as notified
- Assist in the maintenance of a safe company culture by working within the company's environmental, health and safety guidelines and Safety at all times. Report any hazards, equipment or process issues in line with plant escalation procedures
- Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
- Carry out additional duties that may be assigned to you
- A degree in Engineering / Technical discipline with minimum 3 years relevant quality engineering experience
- Internal /lead auditor training is desirable
- Risk management training to ISO14971:2012 is desirable
- Project Management training is advantageous
SKILLS & COMPETENCIES REQUIRED
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), GMP Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971)
- Experience working in a quality engineering role with active involvement within a manufacturing floor (preferably in a medical device setting)
- Experience in working on projects from conception to completion, resulting in significant cost savings and process improvements
- Knowledge of Six Sigma & Lean Manufacturing Techniques
- Quality Awareness and a proven track record of excellent quality standards
- Analytical, data and systems driven approach to problem solving
- Innovative and Proactive
- Organised and resourceful with excellent attention to detail and ability to get the job done
- Ability to work with cross-functional teams, including production, quality, engineering, and materials.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.