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The Contract Quality Technician under general supervision conducts assignments involving a specific phase of an engineering / technician project which may include design, development, manufacturing, construction, installation, operation and maintenance. The incumbent may assist in determining objectives and planning schedules of multiple projects with few complex features.
The Contract Quality Technician will utilize Quality / Technical tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. 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. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
Major Responsibilities & Duties:
• 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.
• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Support 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 and/or support 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.
New Product/Process Introduction
• Supports new product introduction as part of design transfer.
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.
• Review root cause investigation according to an established process.
• Support the collection/presentation of Quality metrics including leading and lagging indicators of quality
• Supports IQ, OQ, PQ, TMV or Software Validation
Production/Process Controls including Control Plans
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Working in conjunction with other senior Quality Engineers, reviews effectiveness of current control plans given risk levels.
• Working in conjunction with other senior Quality Engineers, reviews the level of control in manufacturing processes including the adequacy of current process limits.
• Working in conjunction with other senior Quality Engineers, assess the current risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• A minimum of a Bachelor's Degree is preferred. Generally requires 0-2 year's related experience.
• Experience working in both an FDA and European regulatory environment is an asset
• The ability to perform "hands on " troubleshooting and problem solving. The ability to think independently and provide sound judgment is highly desired.
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