Exciting opportunity for a Senior Quality Engineer to join Ortec Inc. in their brand new facility in Newcastle West, Limerick. The Senior Quality Engineer will provide validation and risk management support for the development of new and existing products.
Overview of Main Responsibilities (full job description available on request):
- Provide quality engineering and process excellence support for existing products covering supply chain, production and post-production processes
- Organize and facilitate quality trending metrics and continuous improvement activities to improve process efficiency, product compliance and control
- Define, implement, maintain, and improve Quality System requirements in the form of Quality Assurance.
- Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures for area of responsibility to ensure compliance with ISO 13485, cGMP, safety standards, and customer and Ortec requirements.
- Provide validation, quality assurance, and risk management support for the development of new products and for existing products.
- Support supplier development and supply assurance for designated components and materials.
- Participate in cross-functional teams that impact product quality, e.g. time to market, increased efficiency, problem solving, generation of cost savings, improving quality, and providing new concepts.
- Participate in and lead internal/external audits as required.
- Participate in design and process evaluations including development of material and product specifications, test methods, and risk analysis.
- Produce and maintain raw material control records, manufacturing batch sheets, and equipment cleaning forms as required for existing products/technologies/processes.
- Ensure that product conforms to specification and control further processing of non-conforming product until the deficiency or unsatisfactory condition has been corrected.
- Provide technical assistance to carry out problem analysis/complaint investigation where necessary e.g. (CAPAs, OOS, Deviations, Supplier Complaints, NC investigations, etc.) and closeout.
- Review documents and forms according to good documentation practices (GDP), e.g. SOP’s, batch records, lab data and reports, raw and intermediate material control records, etc. for accuracy, data integrity and completeness.
- Support product release through preparation and review of CoA/CoC and material labels.
- Track and trend department metrics, KPI and quality indicators.
What the ideal candidate looks like:
- Bachelor’s Degree (Level 8 NFQ) in Sciences or Engineering
- Knowledge of process, test and/or equipment validation preferred
- Minimum 5-8 years’ experience in regulated manufacturing environment. Prefer chemical, pharmaceutical or medical device with quality assurance responsibilities.
- Experience with conducting quality audits and CAPA systems desirable.
For a confidential discussion and more information on the role, please contact Barry O'Brien.