Role: Validation Quality Engineer
Location: Raynham, MA
Emp Type: Permanent Job
A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 3-5 years related experience.
Experience working in both an FDA and European regulatory environment is preferred.
In-depth knowledge of product/process Risk Management (FDA and ISO standards)
Technical training and experience using Statistics, Lean and Six Sigma Methodologies
Good technical understanding of manufacturing equipment and processes is required.
Good experience validations (IQ/OQ/PQ) Understanding of different types of metal/plastic cutting manufacturing processes- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
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.
A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
Demonstrated project management and project leadership abilities are preferred.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
Conduct benchmarking to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. Compliance/Regulatory
Review/analyze 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
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 Product/Process Qualification
Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
Partners with J&J 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.
Develop, interpret and implement standard and non-standard sampling plans
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits. Risk Mitigation
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 Strategic
Ensures effective quality strategies are created for the validation of test methods, process and design.
validation, IQ, OQ, PQ,TMV or Software Validation