SUMMARY

• Ten plus years of quality and project engineering experience in, medical device commercial, high - tech manufacturing, Aerospace and automotive industry.
• Experienced in the implementation of quality programs, audit and procedures.
• Recognized for ability to lead teams in developing new quality methodologies and quality improvements to achieve positive outcomes enabling substantial market share.
• Results driven but diplomatic professional able to work effectively in teams or independently and exceed business as well as customer needs.

PROFESSIONAL EXPERIENCE

Quality Engineer

Confidential

Responsibilities:

• Coaching and mentoring of staff on"best practices", ensuring root cause and corrective actions (or preventive actions, where applicable) are appropriately and efficiently identified for investigations, ensuring comprehensive Verification and/or Validation plans, and ensuring comprehensive and appropriate Effectiveness Criteria.
• Participation in weeklyCAPAReview Board (CRB) meetings, management and issuance of weeklyCAPAstatus reports, driving timely closure
• Evaluate supplier special process validation( IQ/OQ/PQ) as part of the remediation and based on the gaps found, Assess Compliance and product Risk Assessments and present the finding to mgmt.
• Worked on CAPA remediationand special remediation projects. Apply FDA regulations (21CFR82O) and ISO 13485 standards to manufacturing environment, audit quality systems, processes and products and communicate required action to effectively correct findings as expected

Senior Quality Engineer

Confidential

Responsibilities:

• Responsible for handling the full lifecycle of CAPAs including Root Cause Investigations and determining appropriate corrective/preventive actions to mitigate risk associated with Process Deviations, Customer Complaints, and FDA remediation efforts
• Support Manufacturing by performing remediationfailure investigation, process improvement, and, Processing NCMRs, participate in validation writing of protocol activities by reviewing protocols and executing activities where necessary. Updating manufacturing and quality instructions to current standards.
• Actively coordinating various functions across multiple departments to initiate and drive progress of Product, Process, and Consent Decree Work Stream CAPAs.
• Analyze design relatedcomplaintsfrom post market surveillanceand evaluate product (component) returns and complete root cause failure analysis.
• Lead a diverse scope and complexity of problem solving activity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Demonstrate a broad knowledge of a variety of alternatives and their impact on the business unit
• Assisted with eliminating the backlog of open complaints aged greater than 90 days. Streamline the complaint process to facilitate timely investigation and closures of complaints

Senior Product Quality Engineer

Confidential

Responsibilities:

• Verify correctness/completeness of nonconformance description and information 2) identify risk assessment; 3) conduct impact assessment; Propose corrections and containment; 5) conduct investigation to root cause; and 6) send to MRB for possible escalation to CAPA or SCAR and/or closure
• Work with team of consultants using SAP Quality Notification module to investigate and document product non-conformances through their life cycle to closure
• Apply technical and quality knowledge to the analysis, investigation, and solution of product quality problems throughout manufacturing to assure that prompt and effective corrective action is taken
• Respond to customer concerns through the review, investigation and processing of complaints; address product and process issues following internal or external review within the framework of Corrective and Preventive Actions (CAPAs)..
• Multiple NCR's, Customer Complaints, Sustaining Engineering Duties. Assigned as a Lead Quality Systems Auditor. Track wise NCR processing. Approved Final DHR Release records

Quality Engineer

Confidential

Responsibilities:

• Work with CAPA initiators, owners to facilitate effective execution of the CAPA process; coach CAPA owners as they complete each phase of a CAPA project. Review CAPA documents to ensure adequate and complete records of CAPA execution CAPA metrics, trend analysis and supply reports to management that identify key overdue CAPA .
• Manage product complaints using the electronic system. Ensure current and complete complaint files are maintained
• Provides oversight of non-conformance investigations and implementation of corrective and preventive actions while assuring there are adequate product and process controls in place for identified CTQ’s
• Manage product complaints using the electronic system such as (CatsWeb and EtQ). Ensure current and complete complaint files are maintained
• Review, and assess, DHF and deliverables to ensure compliance throughout product development cycle has been approved and review Design History Files and Technical Files for conformance to applicable requirements
• Coordinate, and reviewed complaints for robustness, accuracy and timely completion. Educate CAPA owners on conducting failure investigations and using root cause analysis (RCA) tools

Sr Quality Engineer/Supplier

Confidential

Responsibilities:

• Partner with Operations, Engineering, and other departments to ensure training competencies, resolve technical issues, and implement corrective and preventive actions; manage corrective action process
• Establish/maintain key performance indicators and systems for tracking, reporting and improving performance
• Serve as the key contact for customers on quality-related issues, and for external and internal auditors; manage internal audit program
• Assist with supplier development by evaluating and developing supplier processes through process and product and/or tooling validations and provide assistance, conduct supplier review meetings and supplier training
• Responsible for successful migration to revision C of AS9100; ensure all certifications remain current, Areas of responsibility include quality systems, customer complaints, instrument calibration, approved supplier list, Six Sigma
• Partner with Operations, Engineering, and other departments to ensure training competencies, resolve technical issues, and implement corrective and preventive actions; manage corrective action process
• Assist in development and implementation of a Quality strategy and the Quality goals and objectives required to support the business DMAIC improvement model: Project Charter, Process Map, Thought Process Map, Pareto Chart, Trend Chart, Fishbone Diagram, 5-Why Analysis, Histogram, SPC, FMEA, Benchmarking, Brainstorming, 5S, Correlation Analysis, Error-proofing, Cpk, Corrective Action Matrix, and Continual Improvement.
• Perform thorough supplier audits and assessments of their processes, QMS and drive improvement