Quality Engineer 2

This is a full-time position to work Monday to Friday from 8:00am to 5:00pm in our Heredia Site, located in Zona Franca Metropolitana. Remote work might be allowed based on business needs.

Our Quality Engineers 2 provides 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 Responsibilities:

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.

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 execute

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).

Knowledge / Education

Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).

Bilingual English/Spanish – Intermediate English level, reading and listening comprehension, writing and oral expression.

Basic knowledge and application of statistical techniques (Sampling Plans, Gage R&R’s, Hypothesis Test, Process Capability Studies).

Basic knowledge of applicable regulations for the medical device industry (FDA, ISO, other.)

Basic knowledge in root cause analysis tools.

Basic knowledge and application of risk management (PFMEA’s).

Basic knowledge of process validation.

Knowledge of Six Sigma Methodology and Lean Manufacturing is a plus.

Knowledge of Minitab statistical software is a plus.

Job Experience 

At least 1 year work experience in manufacturing environment.

Project Management experience is a plus.

Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus.

Skills / Competencies Good interpersonal skills and the ability to communicate orally and in writing.Self-motivated. Organized and able to manage multiple tasks and priorities.Must be able to read and understand specifications. Proficient in the interpretation of technical drawings.Must be able to work and effectively communicate with others.Highest ethical standards and professional integrity. Able to work independently.Teamwork oriented.ProactiveDisciplineCustomer orientedTeam playerDiligentRetentiveGood learnerHands-on, collaborative, decisive.Must be flexible and adapt to changing environments and priorities.LeadershipEffective presentation skills and ability deliver insightful messages to external and internal audiences.Problem Solving: Must be able to formulate problem statement, identify and gather applicable data/evidence.Metrology: Capable of writing measuring procedures and test method work instructions.Decision making: Capable of doing risk assessment and making low risk decisions.