Description
I have an immediate opening for a Quality Validation Engineer with a well respected and fast growing medical device company in Co. Roscommon. This is a great opportunity to join a company who offer great opportunities for career progression.You will have 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.
Responsibilities:
- Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with the 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 support to the NPI engineers and sales to define validation plans and times to meet customer 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 meet the requirements of end users, customers, regulatory authorities and the company.
Requirements:
- A primary degree in engineering or equivalent.
- A qualification in quality management is desirable.
- S/he should have a minimum of 5 years in a technical role, min 3 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.
If you feel you are a good fit dfor this role please apply directly to this advert or contact Derek Sheridan on .