JWR Employment Specialists are working with a Medical device company in Boyle Roscommon to recruit at Manufacturing Quality Engineer. The person in this role will be responsible for ensuring that our manufacturing processes, products and systems are in compliance with our requirements and who will identify and manage investigations into non-confirming events and complaints.
About the Company.
Our client designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart. Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Our client works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.
Further responsibilities are:
- Act as the Manufacturing Lead with respect to process monitoring and key quality control points ensuring negative trends are addressed.
- Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
- Process Audits of the manufacturing lines to ensure the product being manufactured and our equipment and process comply with all requirements.
- In conjunction with the Manufacturing Engineer, provide product line support for the production department, approve documentation for extrusion equipment and process and execute validations for product process and technology.
- Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality. Be an active lead 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. Maintain effective open communication within the team and foster cross- functional relationships
- Conduct Competence Assessment with manufacturing personnel
- Deputize for our Site Quality manager in his/her absence.
Education and Experience Requirements
- Degree or equivalent in Engineering/ Quality or Science discipline or equivalent in Polymer, Manufacturing or Mechanical Engineering.
- Medical device manufacturing experience is essential.
- Manufacturing, Engineering or Process Quality experience in similar position (4 plus years beneficial).
- Good working knowledge of production and quality system requirements in the health care industry (13485 and FDA QSR Parts 820) required.
- Green or Black Belt in Lean Six Sigma would be a distinct advantage.
Skills and Abilities
- Ability to work hands-on engaging with cross-functional groups, equipment and materials vendors to resolve technical issues.
- Strong communication & influencing skills and ability to effectively manage a simultaneous range of diverse activities.
- Self-starter with good motivational and inter-personal skills.
- Practical level-headed individual with strong technical ability.
- A structured approach to problem solving based on the utilization of data.
- Willingness to travel when required.