Sr. Engineer Quality Assurance
BECTON DICKINSON AND COMPANY
Total des années d'expérience :10 years, 0 Mois
Responsible for being the prime quality representative for design control projects at the BD UCC (Urology and Critical Care) Site.
• Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
• Responsible for review and approval of design history file documentation in support of design controls, ensuring product technical files and Design History Files are complete and auditable.
• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
• Leading ISO 13485 QMS audit for Software Technology Solutions, India site.
• Works together with SW Quality Engineers to ensure effective verification of design specifications and requirements.
• Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
• Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation.
• Active participant in the development of product requirements, product system hazard analysis and design reviews.
Responsible for implementation, handling and addressing routine Quality compliance systems and processes related to Quality Management System (QMS), Change Management, Supplier Quality Assurance and provide inputs towards their effective resolution in collaboration with relevant counterparts.
• Working with APAC Core quality team as a Country QA representative for implementing Global QMS changes related to process & determining the risk and implementation plan.
• Implement, Track and Trend Quality Change Order’s (QCH), Record change orders (RCH), Deviations (DVN), Data change orders (DCN) in Agile platform, by collaboration with BU for successful implementation.
• Working on Product Complaint Handling process, requirements for the complaint intake, investigation, documentation, reporting and closure of product complaints.
• Independently executing Supplier & Distributor Management Process and creating Quality Agreements and Supplier Change Control Agreements for OEMs/CM/ Service suppliers. Review & Closure of Supplier Audit NC / CAPA as per Medtronic business process guidelines.
• Leading ISO 13485 external supplier qualification audits for OEMs & Technical Service suppliers supporting Medtronic’s global Business units.
• Works directly with cross functional teams (OUs & BUs) for product qualification to enforce requirements and meet requirements.
Worked with Stryker’s Global Merger & Acquisition Team. M&A team is involved in the on-boarding process of the suppliers, supplier audits, Change control agreements & Quality agreements execution, Supplier audit Nonconformance closure.
• Key Player in Merger & Acquisition audits of new Onboarding Suppliers, consolidating Site quality performance data for suppliers and determining the scope of the self-assessment audits during pre-assessment meetings.
• Conducting Supplier’s Pre-Assessment / Post assessments, Supplier Audits by collaborating with Sourcing, R&D & Division QA Leads.
• Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review & Approval.
• Creating Quality Agreements and Supplier Change Control Agreements for OEMs/CM/Component suppliers for the merger and acquisition suppliers and review with the Site stakeholders.
• Review and Closure of Supplier Audit Non-Conformities as per Stryker’s NC & CAPA procedure and ensuring the implementation of the corrective actions at the supplier end.
• Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) as per ISO 13485 & CFR 21 Part 820 requirements.
Monitoring & Development of the Quality Management System at Plant level, ensuring ISO compliance, managing the engineering Change Process across the Organization.
• Implementation & Development of documentation for ISO 9001:2015 standard, including Control Plans, Process Control Sheets, SOPs, PFMEA, Flow Diagrams, WIs, Quality Objectives etc.
• Conducting Quality Internal Audits followed by Management Review Meeting as per ISO 9001: 2015 requirements.
• Closure of Nonconformities observed during External audits & Customer audits with effective CAPA.
• Assessed and addressed Customer Complaints (internal & External) and coordinated Corrective Action efforts from initial investigation (RCA) to successful implementation of Permanent Corrective Actions (8D reports).
• Perform onsite Supplier Quality and Process Audits, lead in the Supplier Quality Development Plans and Continuous Improvement and lead in CAPA investigations.
• Participated in Advanced Product Quality Planning (APQP) process to achieve production part approval (PPAP) for designated suppliers in support of new product launches.
• Analyze incoming material defects (mechanical, electrical & plastic parts), disposition and drive corrective or preventive action as necessary and communicate any issues to suppliers using 8D\Six Sigma.
• Documenting HIRA (hazard identification & risk assessment), AIA (Aspect Impact Analysis) & OCPs as per EHS 14001 & OHSAS 18001 guidelines
• Improving overall production efficiency by working together with production and maintenance departments in developing and modifying tooling and fixtures
• Define error proofing in manufacturing process to avoid and bypass any error and discrepancy in the product in coordination with Process Engineering
• Determining Gauge R&R for critical Equipment to avoid BIAS in measurement system & ensuring timely calibration of instruments via internal / external calibration to avoid any BIAS in instruments
B. Tech in electronics & Communication