Validation Engineer – Longford
1. Purpose of position:
The Manufacturing Quality Engineer has responsibility for the effectiveness of assigned areas of the company’s quality system and for completing validations of process and products as required. S/he will also provide validation and manufacturing quality support to the new product introduction manufacturing teams. Championing a structured approach to problem solving and error proofing using 6 sigma and lean principles.
2. Principal Duties and responsibilities:
•Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with ANSAmed quality system and the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations.
•Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice
•Provide training and guidance to others on validations as required.
•Provide support to the NPI engineers and sales to define validation plans and times to meet customer and ANSAmed requirements.
•Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control.
•Provide manufacturing quality engineering support for current business to improve quality through improved manufacturing processes and process control.
•Effective and efficient execution of validation and other projects : Achieve key project deliverables on time and within budget
•Champion structured approach to problem solving within the organisation using cross-functional teams and six – sigma methodology.
•Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
•Project manage and lead cross functional teams with responsibility for the introduction and validation of new processes/ new technology.
•Work with equipment vendors to mutually understand their and our technical process challenges to improve capability, eliminate cost and improve effectiveness of validations.
•Assess customer’s validation needs and propose innovative solutions.
•Maintain validation and other records in accordance with the quality system requirements, which show that products manufactured by ANSAmed meet the requirements of end users, customers, regulatory authorities and the company.
•Maintain the plants calibration system and equipment calibrations as assigned
•Maintain assigned areas of the ANSAmed quality system in accordance with the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations.
•Identify areas for improvement and lead improvement initiatives.
•Investigate, trouble shoot, disposition and report on validation failures, system failures, non conforming products and other product defects. Champion a structured approach to problem solving within process improvement teams.
•Maintain and report on quality trending data as assigned
•Identify and implement process controls including SPC as required
•Investigate, report on, and respond to customer complaints as assigned
3. Person Specification:
•A primary degree in engineering or equivalent.
•A qualification in quality management is desirable.
•S/he should have a minimum of 3 years in a technical role, min 2 years medical device/pharmaceutical and/or diagnostics manufacturing experience including
•S/he should have a minimum of 5 years medical device/pharmaceutical and/or diagnostics manufacturing experience. At least 5 years in a technical department and at least 1 year in a quality department is desirable. Experience in a polymer extrusion operation is advantageous.
•Must have a good working knowledge of ISO13485, FDA Quality System Regulations.
•Self starter with good inter-personal skills. Ability to multi-task is essential.
•S/he should have strong analytical communication, organisational and influencing skills.
•S/he should have an ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues.
•Excellent project management skills, setting realistic objectives and delivering
•Energetic and driven self-starter, with good communication and influencing skills and the ability to effectively simultaneously manage a wide range of diverse activities.
•Must be commercial, understanding the revenue generating aspects of small business and the cost implications of providing technical and validation solutions, in a timely manner.
•Liaise with customers, being available to support sales, from a technical validation perspective
•Proficient in the use of word, excel and statistics software
For more information please contact Sylvester on 0949029944