MANUFACTURING QUALITY ENGINEER
MANUFACTURING QUALITY ENGINEER – Roscommon
- The role is to ensure that the Manufacturing Processes, Products, and Systems are in compliance with the requirements set out in Validations, Customer Specifications, Quality & Manufacturing Specifications, Control Plans, and relevant International Standards as applicable.
- Act as the Manufacturing Lead with respect to the thorough investigation of Non-Conforming Materials and Complaints, using Data Analysis/Problem Solving Techniques to arrive at Root Cause and identify Corrective & Preventative Actions to prevent recurrence
- Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant EXPS (Set-Up Sheets) and Standard Operating Procedures
- The review of Batch Records to ensure the product and Lot History documentation are in compliance prior to QA Final Release.
- Generation and Revision of EXPS (Set-Up Sheets) and Tube Specifications (Product Specifications) to ensure all relevant Quality and Process/Equipment requirements are captured
- Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality
- In conjunction with the Manufacturing Engineer, provide advice and support to processes that require investigation or development with the goal to improve and make robust.
- Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements.
- Support the Manufacturing Engineer and cross functional teams on the collation of data and the resolution of processing issues.
- Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department
- Lead Manufacturing Driven initiatives with respect to quality within the department
- Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release.
- Maintain effective open communication within the team and foster cross- functional relationships
- Conduct Training and Competence Assessment with manufacturing personnel on changes being introduced as required
- Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
- Maintain work areas, equipment and supplies in a manner which conforms to the requirements of the Vention quality system, 5S, GMP and safety.
- The Manufacturing Quality Engineer will have a primary degree or equivalent in polymer, manufacturing or mechanical engineering or have 4 plus years Extrusion Manufacturing or Process Quality/Engineering experience.
- Medical device manufacturing experience is essential.
- Hands on experience in extrusion and plastics material knowledge are essential.
- Must have a good working knowledge of production and quality system requirements in the health care industry (13485:2003 and FDA QSR Parts 820)
- A Green or Black Belt in Lean Six Sigma would be a distinct advantage.
- S/he needs strong communication and influencing skills.
- Have the ability to effectively manage a simultaneous range of diverse activities.
- Be a self-starter with good motivational and inter-personal skills.
- A Practical level-headed individual with strong technical ability.
- Have an ability to work hands-on engaging with cross-functional groups , equipment and materials vendors to resolve technical issues.
- A structured approach to problem solving based on the utilisation of data.
For more details please send in your CV in word format and contact Sylvester on 0949029944