Sr. Quality Supervisor
Medtronic
مجموع سنوات الخبرة :9 years, 9 أشهر
• Develops, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product by collaborating with R&D and manufacturing functions to ensure quality standards are mitigated.
• Collaborates with R & D Engineers and concurrent Engineers to develop and deliver the Product Acceptance Sampling Strategy, Supplier Owned Quality deployment, and Control Plans.
• Ensures corrective measures meet acceptable reliability standards and documentation is compliant with requirements of Quality Systems, Design Controls and Risk Management for Reliability to streamline processes
• Experience and knowledge of medical device standards including ISO 13485, 21CFR 820, ISO 14971, IEC 62366 etc.
• Interface with functional areas to obtain information and docs required for the development of PMS Plans & Reports.
• Provides technical guidance and quality compliance for Internal Supplier Quality engagement and continuous improvement.
• Ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Lead the development, sustenance and continual improvement of quality systems complying with 21 CFR 820 and ISO 13485 quality system requirements with a specific focus on design control including defect management.
• Contribute to develop Design Control policies and Design Reviews procedures to ensure compliance with appropriate standards, regulations, and industry best practice.
• Responsible for accurate, independent evaluation of Design History File documentation and overall compliance to the Quality System
• Analyze complaint data and investigate cross functionally to identify the root cause & share feedback to the development and manufacturing teams on potential product improvements to mitigate complaints by assessing if the Risk assessment is covering the hazard in the complaint.
• Good understanding of product development and general guideline regulations such as ISO 13485, ISO 14971, Design controls, robust design and ability to apply the tools is expected.
• Applies technical expertise to complex tasks with in-depth knowledge of related work areas.
• Ongoing quality oversight via effective management and coordination of Quality Management Systems including change control, Non-conformance, CAPA and metrices.
• Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Member of Validation team for Various Projects as to design & develop medical devices including technical documentation and specifications in collaboration with external suppliers and internal departments.
• Make sure (100 %) adherence Risk Assessment for all critical Equipment & Process Risk execution using relevant methodologies, tools, and techniques.
• Review/analyze whether current product and processes are complying to standards to meet applicable Global compliance/Regulations and standards (e.g. QSRs, ISO, IEC, EN, MDD & MDR).
• Lead with global 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.
• Actively participates in evaluation and defining CAPA/ action plan / Investigations & agrees with plan and its implementation time lines with applicable standards.
• Validating HVAC system of clean room as well as ETO Machine periodically for compliance requirements, biological reactivity, sterility of products / material characterization tests.
• Ensure the compliance of the product through testing as per specification, change management, stability studies, deviation and investigation, OOS and market complaint systems
• Provides statistical support and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits.
• Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Responsible for assessing Quality trends through APQR’s and driving Continuous improvement for processes and product quality performance.
• Prepare & maintain of the Post Market Surveillance docs in the repository for audit readiness.
• Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Design and Issuing the Quarterly / Annually Post market surveillance (PMS) Plan for Medical devices. Interacting with data contributors across the organization, in order to get data.
• Plan, schedule, and lead project assignments using appropriate engineering techniques with minimal guidance by launching project charter, process map, stakeholder analysis, SIPOC, CTQ and Gantt chart to track project progress.
• To continuously evaluate the quality risks and escalate all potential quality issues and risks and initiate all actions as defined.
• Operate design software to design, layout, produce drawings & Participate in product design reviews and provide input on design-based experience and knowledge.
• Make sure (100 %) adherence Risk Assessment for all critical Equipment & Process Risk process execution using relevant methodologies, tools, and techniques.
• Issue Supplier Corrective Action Requests (SCARs) and ensure suppliers implement robust corrective action which prevent recurrence (CAPA’s).
• To lead, participate, support the projects of technology transfer/Continuous Improvement projects for new products or existing products identified and allocated as per project Management.
• Present Periodic Supplier Performance Review for area of responsibility with comparative data and metric performance.
• Continuous improvement of process effectiveness and efficiency through variety of Quality & Continuous Process Improvement.
• Participates with Corporate and regional Supplier Quality teams on policy/procedure/ guideline development to includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs.
• Validating HVAC system of clean room, Sterilizer equipment and process periodically for compliance requirements, biological reactivity, sterility of products / material characterization tests.
• Preparing technical construction files along with relevant docs for CE marking as per EU MDR 2017/745 & working on continuous process improvements for enhancing the operational efficiencies.
• Scheduled brainstorming session with primary stakeholders and QI mentors to create FMEA, fishbone diagram and PDSA cycle.
• Utilized DMAIC Methodology for improving performance of equipment, quality of product and cost of labor utilization & equipment utilization, assisted in new product & process development by validating product flows and equipment qualification.
• Maintaining Q.M.S Documentation as per standard/guideline requirements.
• Log Internal complaints and provide corresponding CAPAs. Perform the Investigation of Nonconformities Root cause identification and determination in defined lead time
• Developed production work orders and bill of materials (BOM) for upcoming project by using Quality standards, performance metrics and assembly instructions related to production
• Developed & maintained SOP, STP, Records, Protocols and cost avoidance defect reports for Corrective Action/Preventative Action (CAPA)
• Completion of all design requirements as and when the new designs are introduced.
• Updating the Technical file, DMF as per the changes in requirements with MDD 93/42/EEC.
• Preparation and review of SOPs &FAT/SAT, IQ/OQ/PQ protocols as per WHO TRS for validation/ revalidation.
• Verified, validated and controlled manufacturing process using Direct Time Study, Work Sampling & Measurement techniques.
• Optimized standard work procedure and analyzed alternative assembly line by Value Stream Mapping
• Responsible to feed defect free parts to assembly on time.
• Develop and maintain batch records for each released batch.
• Monitoring of Clean Room and other associated areas.
• Perform the IPQA activity (100 %) at shop floor to ensure the critical process meeting the product required specification.
• Maintain effectiveness of IMS, Quality Systems & Product Certification as per ISO 13485 & ISO 9001.
• Responsible for kaizen declared by company for specific task.
• Developing, implementing & maintaining quality assurance policies and ensuring that performance and quality conform to company's quality objectives & international standards as per MDD.