Las Visión de Conjunto:
The
**Sr Quality Engineer - PAL** perform investigations related to customer complaints, either for router sheets related to the complaints or for the product returned for analysis, to detect possible root causes on the failures and provide an answer to the customers.
Execute problem solving skills during investigation with the intention of identifying root causes and corrective and preventive actions related to the issues analyzed. Ranks, prioritizes and accurately manages different aspects of complaints as required by company and local/international government regulations.
Analyze departmental issues and work with improvement projects related to cost reduction, and process improvement or compliance improvement.
**Responsabilidades**:
- Product complaint analysts and PAL personnel as appropriate.
- Investigates and processes product complaints, while maintaining compliance to all regulations
- Performs/Document Product History Reviews and Product Evaluation properly and following GDP's.
- Maintain communication with Engineering teams in order to review deeply complaints that may be related to a manufacturing and/or design issue.
- Devises new approaches to problems encountered and identifies process improvement opportunities.
- Perform measuring, testing and analysis on the returned devices to determine the root causes of the issues presented. (e.g. dimensional inspection with rule, caliper, laser micrometer, etc.; also, perform functional testing by using pull testers, leak testers, and other equipment as required)
- Document the investigation in the applicable Global Complaint Handling System applicable, following Cordis Politics and procedures, and as well as required per applicable regulations.
- May be required to perform specialized studies such SEM analysis, X-Ray analysis, and others analyses as applicable.
- Comply with internal departmental metrics and with the Complaint Handling and Safety Surveillance departmental metrics.
- Address investigations to document Audit Observations, CAPA Actions, non-conformances, and any other investigation as applicable.
- Participate in QA operation/Management meetings to present complaint trending analysis per area as applicable and required typically as a leader of this activity.
- Maintain appropriate level of knowledge on product and processes manufactured by the company and OEM's as required.
- Escalate manufacturing and design issues related properly and in a timely manner to investigate further on the failure found and to allow the implementation of the corrective/preventive actions detected during investigations.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
- Work with complex projects to support improvement activities in the department.
- Perform Complaint Trending Analysis and escalate as appropriate.
- May be responsible to complete validation activities related to laboratory equipment.
Calificaciones:
- Bachelor's degree in related field is required.
- Experience in the medical device industry would be an asset.
- 4 years of experience as quality engineer required or 3 years in the complaints handling / analysis area as minimum is preferred.
**REQUIRED KNOWLEDGE, SKILLS, ABILITIES**
- Excellent written and oral English communication skills
- Problem Solving Skills is required.
- Computer literate of MS Word, MS PowerPoint, MS Excel a plus
- Ability to interact with individual/groups at all levels
- Ability to identify priorities and function independently
- Ability to present information to upper management.
- Ability to work with complex projects.
- Quality Auditor/Quality Engineer certification is desirable (CQA/CQE)
- Analytical thinking
- Measurement systems knowledge
- Experience in materials analysis with different methodologies such FTIR, TGA, SEM, DMA, EDS, DRx, etc.,, characterization of materials is highly desirable
- Position requires to work in a laboratory environment
- Position requires to be enrolled in a medical vigilance program