Orion Group Life Sciences have an exciting opportunity for a Quality Operations Engineer for our Multinational Medical Devices client based in the Cork area on an initial 12-month contract.
The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
Main Responsibilities of the role
* Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
* Review/analyze whether current product and processes (including actions or decisions conducted) comply 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.
* Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
* Supports activities related to the Material Review Board.
* 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.
* Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
* 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.
* Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
* Document, justify, review or analyze 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
Desired Experience and Background of the successful candidate
* A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience.
* Experience working in both an FDA and European regulatory environment is preferred.
* This position will require relevant experience working in manufacturing/operations.
* In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
* Experience with a proven track record of implementing appropriate risk mitigation.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
* The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
* 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.
* Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
* Demonstrated project management and project leadership abilities are preferred.
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For more information on this role, call Shane O' Neill on 353212063407 or email firstname.lastname@example.org for a completely confidential chat about this role and other opportunities using the reference number: 930613
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.