Orion Group Life Sciences have an exciting opportunity for a Senior Quality Engineer for our Multinational Medical Devices client based in the Limerick area on an initial 12 -month contract.
Provides quality leadership and support to business units. Leads root cause investigation activities and drives continuous improvements, The Senior Engineer is an emerging authority in the Business Unit quality management including non-conformance management, CAPA investigations and activity closure, validation documentation review and approvals, complaint investigations/trends, internal and external audits support etc.
− Business Unit Non-Conformance (NC), CAPA, Complaints and Validations management
− This includes investigations related to NC’s and complaints, trending of same and assessing need for CAPA.
− Responsible for investigation/disposition of on hold product and material (including supplier related holds) up to and including escalation to MRB
− Support both Internal and external audits, act as Business Unit Subject Matter Expert
− Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
− Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
− Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
− Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
− Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Product Quality, Control & Disposition and Performance Standards
− Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
− Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
− Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
− Approve IQ, OQ, PQ, TMV or Software Validation
− Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
− Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
− Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
− Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
− Partake in Change Request (CR) management for the Business Unit enduring appropriate and timely review and approval of CR’s in partnership with Business Unit peers.
− Document, justify, review or analyse whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
− Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Education and Experience
−A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
− Requires 5-8 years related experience.
− Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
− Experience with a proven track record of implementing appropriate risk mitigation.
− In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
− Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.
− Good technical understanding of manufacturing equipment and processes is required.
− Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
− A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
− Strong mentoring, coaching and leadership skills are required.
− Demonstrated project management and project leadership abilities are required..
#medicaldevices #medical #device #13485 #multinational #product #implant
For more information on this role, call Dan on (phone number removed) or (url removed) for a completely confidential chat about this role
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Job Type: Contract
To apply for this job please visit www.cv-library.ie.