Quality Engineer Resume Hudson, MA - Hire IT People

PROFESSIONAL EXPERIENCE

Confidential, Hudson, MA

Quality Engineer

Responsibilities:

Manages the CAPA/NCR/RMA protocols by performing root cause analysis, recommending, writing and implementing corrective action and perform training.
Develop and conduct process validation (IQ/OQ/PQ) risk analysis (PFMEA), experimental design (DOE) and Test Method Validation along with the Engineering team
Responsible for assessing and developing inspection methods, test methods and tools for operations
Support Customer service to review customer prints for determining measurements, methods and quality plans
Responsible for managing the company calibration program for metrology and process equipment
Responsible for writing and revising SOPs, Work Instruction and Quality management systems documentations

Confidential, Andover, MA

Quality Complaint Investigator

Responsibilities:

Handle complaint investigations in accordance with internal and external (FDA, Canadian and European) regulatory requirements
Investigate customer complaints related to product quality and patient safety (relating to open/pending CAPA’s, MDV reporting, Canada & EU Competence Authorities reporting)
Work with R&D and Philips Bench Repair to support the investigation of clinical and technical issues
Verify reported problem with the Customer to establish a root cause
Communicate and support customers (External End User, Philips Adverse Event Coordinators, Analysis Lab, Bench Repair, BioMed Technicians and Field Service Engineers) by processing and analyzing business related customer feedback information according to GMP, FDA and ISO standards
Update customer feedback information into database tools (SAP, TrackWise and eDHT) to ensure regulatory compliance
Record and document defective devices via the RMA protocol
Process and evaluate backlog complaints as necessary per process
Support the compiling and reporting of complaint metrics for the Quality department

Confidential

Quality Engineer

Responsibilities:

Constant monitoring and updating of CAPA investigations
Daily monitoring and investigating of complaints and communicate the information to the Risk Assessment Board
Update Quality documentations to maintain company compliance
Maintain and monitor complaints from Customers and Field Service Engineers to establish root cause (Salesforce database)
Work with in - house Engineers, Manufacturing, Materials, Quality Control, and Customer/Field Service along with interactions with external entities including contractors, suppliers, and customers to close out open cases or issues
Update in-house CT scanner Quality Testing and Qualification WIs and SOPs for efficiency and accuracy
Evaluate Quality systems and recommend possible changes and updates based on track and trending data
Assumed a regulatory role to close an injury case that occurred outside of the U.S. (including MEDDEV and FDA reporting)
Constantly update the Quality Department Risk Management documents (per ISO 14971)
Provide daily feedbacks to Engineering and Service Departments to achieve field issue resolutions

Confidential, Andover, MA

Quality Complaint Investigator

Responsibilities:

Handle complaint investigations in accordance with internal and external (FDA, Canadian and European) regulatory requirements
Investigate customer complaints related to product quality and patient safety (relating to open/pending CAPA’s, MDV reporting, Canadian & EU Competence Authorities reporting)
Work with R&D and Philips Bench Repair to support the investigation of clinical and technical issues
Verify reported problem with the Customer to establish a root cause
Communicate and support customers (External End User, Philips Adverse Event Coordinators, Analysis Lab, Bench Repair, BioMed Technicians and Field Service Engineers) by processing and analyzing business related customer feedback information according to GMP, FDA and ISO standards
Update customer feedback information into database tools (SAP, TrackWise and eDHT) to ensure regulatory compliance
Record and document defective devices via the RMA protocol
Process and evaluate backlog complaints as necessary per process
Support the compiling and reporting of complaint metrics for the Quality department