**Job Title**: Quality Engineer (Process, Systems and Supplier)
**Department**: Quality Assurance
**Document Purpose**: this document serves as guidance to establish the professional classification in the quality engineering area, defining specific and general activities that require revision on each position to establish the correct scope and responsibility.
**Main Purpose of Job**: (Brief Summary)
Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier quality management. Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology. Participate in or lead Corrective/Preventive Action initiatives. Support internal/ external and suppliers audit, vendor qualification and training programs. Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects.
Main Job Duties/Responsibilities
**Category 1 (Grade 4)**:
- Prepare and update quality documents and any applicable documentation required to sustain the manufacturing process, system or NPI projects, including but not limited to documentation linked to the Device Master Records and Device History Records.
- Execute reviewing / approval of any documentation created / updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
- Support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems or supplier improvements.
- Checks, provides support and executes initiation / investigation for NCs, Complaints, Calibration, SCARs and Environmental Monitoring.
- Provide follow up to actions generated from corrective and preventive plans.
- Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
Maintain and follow up CAPA and supplier files. (Quality Systems and Supplier Engineer only).
Support in the execution of qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.
**Category 2 (Grade 5)**:
- All duties listed for Category 1.
- Assure that all laboratory equipment is in compliance to perform the analysis and testing activities (quality labs, calibration, microbiology and incoming).
- Participates in all the readiness activities required to receive Internal / External / Customer / Suppliers Quality System Audits.
- Collaborate in the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
- Review protocols and reports for IQ, OQ, PQ, PPQ and TMV; as well as any other document related to validation.
- Prepare respective validation protocols and reports for low and moderate complexity qualifications or participate in the approval of them. Participates on the definition of validation strategies.
- Elaboration of Validation Master Plans to define / document all the validation strategy required to implement a new product / process or change a current one. Also, elaborate the Validation Master Plan Closure once all the activities have been executed
- Read and interpret technical drawings provided by the customer and elaborates the related documentation such as of QA Specs, Control Plans, other.
- Elaboration of work instructions, automated routines or any other document required to execute inspections. Also, validate these inspections through TMV Protocols and TMV Reports..
- Participate in the communications with the customers including projects, product/process transfers, weekly sustaining report out meetings, Quarterly Business Reviews, other.
- Provide new hire introduction sessions. (Quality Process and Quality Systems Engineer only).
- Create quarterly suppliers evaluation, scorecards. (Supplier Quality Engineer only).
- Purchasing control of approved suppliers through the document change control process. (Supplier Quality Engineer only).
**Category 3 (Grade 6)**:
- All duties listed for category 1 and 2.
- Coordinate the development of new processes inspections by interfacing with personnel from product design and development, quality assurance, production, manufacturing, process/assembly technology and external vendors / customers.
- Participate in the preparation of quality metrics required for Management Review, Operations Review or Quality Metrics meetings.
- Review drawings, analyze tooling, and recommend improvements leading to increase productivity, quality, and safety for new or existing manufacturing processes.
- Coordinate and c