Quality Engineer - Costa Rica

Summary

The Quality Engineer is responsible for maintaining the Quality Management Systems ensuring product compliance to internal and customer specifications as well as compliance to MGS processes. Additionally, they will be responsible for ensuring that new products meet all customer and MGS quality and documentation requirements when they are launched into production.  This is accomplished by developing and validating measurement systems, establishing in-process quality plans, validating production processes, submitting documentation for customer approval, and transferring knowledge.

Essential Functions

Qualification for this position is predicated not only on satisfactory performance of essential duties as outlined below, but also on compliance with general company policies and procedures and any other duties as assigned.   Strict compliance with Company’s Attendance Policy is considered an essential duty and responsibility.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

General Company Requirements

• Know and follow all Company safety rules, such as safe work practices and standard operating procedures.  

• Serve as a good role model to employees for safe work practices and behavior by conducting yourself professionally, keeping in mind your own safety and the safety of others. 

• Learn and master all necessary areas of the quality system.

• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

General Role Requirements

·         Address customer complaints and internal quality issues.

o   Initiate the corrective action process and use the appropriate quality tools to ensure that the problem is satisfactorily resolved. 

o   Investigate issues and acquire input from subject matter experts.

o   Interface with customers.

o   Drive the team to implement permanent corrective actions.

o   Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.

o   Record all actions on internal and customer-specific documentation, including updating customer portals.

·         Address suspect and non-conforming product.

o   Initiate stop-ship and containment activities.

o   Initiate RMA process for product in customer’s possession.

o   Recommend disposition of product.

o   Develop inspection/sort/rework instructions.

o   Develop customer waiver (deviation) documentation and obtain customer approval, if required.

·         Maintain the Quality Management System (QMS).

o   Understand ISO-9001 Quality management systems – Requirements.

o   Ensure continuing compliance to both internal MGS processes as well as requirements imposed upon MGS by certification bodies, regulatory agencies, and specific customer requirements.  See below for additional requirements for automotive and medical products.

o   Perform Layered Process Audits.

o   Assist in 2nd party, 3rd party, and internal audits.

o   Assist in responses and corrective actions for audit findings.

• Approve product for shipment.

  • Perform batch record reviews.

  • Generate Certificate of Analysis, as required.

  • Release product in ERP system.

• Support engineering change process.

  • Interface with customer to ensure compliance to customer request and requirements.

  • Manage product inspection and testing activities.

o   Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.

• Complete required documentation.

• Submit documents to customer and obtain customer approval.

• Support Operations.

  • Resolve inspection issues to allow product movement in a timely manner.

  • Update production documents when errors are found.

  • Train production and QC staff on customer requirements, inspection techniques, and rework instructions.

·         Support advanced product quality planning

o   Participate in design review, process planning, and failure mode analysis

o   Provide input on the selection of Key Product Characteristics

o   Provide input on gaging methods and equipment

·         Generate quality plans for new product launches

o   Incorporate documented customer requirements

o   Incorporate industry standard practices

o   Incorporate MGS lessons learned

o   For industrial, commercial, and automotive customers, generate and get customer acceptance of a PPAP plan

o   For medical customers, generate and get customer acceptance of an IQ/OQ/PQ protocol

·         Develop and validate measurement systems

o   Interface with gage & equipment manufactures to ensure understanding of requirements

o   Establish validation plans/protocols

o   Ensure validation is completed and that all requirements are met (FAT)

o   Generate clear instructions for gage end-users

o   Perform MSA studies and ensure that Gage R&R is acceptable

o   Generate and document golden samples and/or challenge parts

• Obtain customer approval

  • Compile measurement and process performance data

  • Assemble documentation package

  • Review for completeness and accuracy

  • Drive correction of all errors

  • Submit to customer and drive for approval

• Release production documentation in the document control system

·         Transfer knowledge to Operations through reviews and training

·         Any other duties as assigned.

Requirements for Medical Product Focus

·         Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.

·         Understand 21 CFR Part 820 Quality System Regulation – Good Manufacturing Practice for the Medical Devices.

·         Understand cleanroom gowning practices and cleanliness requirements for manufacturing within a cleanroom.

·         Understand medical customer-specific requirements.

Requirements for Automotive Focus

·         Understand IATF 16949 Quality management system requirements for automotive production and relevant service parts organizations.

·         Understand data collection, documentation, and reporting requirements for Controlled Shipping Level 1 and Level 2 (CS-1 and CS-2).

·         Understand automotive customer-specific requirements.

Competencies

·         Positive Attitude

·         Teamwork and Cooperation

·         Flexibility

·         Initiative

·         Judgement

·         Customer Focused

·         Organization

·         Attention to Detail

·         Ability to multi-task

·         Critical thinking

·         Communication skills

Supervisory Responsibility

·         N/A

Qualifications, Education, Experience, and Training

·         High School Diploma or equivalent is required.

·         BS degree in engineer or business is preferred.

·         Three to five years of experience and/or training, or equivalent combination of education and experience.

·         Demonstrated experience in problem solving.

·         Demonstrated statistical analysis skills.

·         GD&T experience.

·         Experience in working with teams to achieve results.

·         Language Skills

o   Ability to read, write, comprehend, and communicate the English language in a proficient manner. Bilingual is a plus.

·         Computer Skills

o   Good understanding and ability to perform tasks and create documents using Microsoft Word, Excel, PowerPoint, Access, and Outlook. 

·         Math Skills

o   Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.

·         Reasoning Ability

o   Ability to carry out written or oral instructions.

o   Ability to deal with complex problems.

o   Advanced application of inductive and deductive reasoning.

·         Travel

o   Occasional travel to customer sites as needed (<10%).

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

·         Regularly exposed to moving mechanical parts. 

·         Occasionally exposed to fumes or airborne particles. 

·         The noise level can be loud.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Regularly required to use hands to finger, handle, or feel and talk or hear. 

• Required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. 

• Occasionally lift and/or move up to 50 lbs.

• Specific vision abilities required by this job include close vision.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities may change at any time with or without notice.

This job description has been reviewed and the required tasks, duties, and responsibilities required to perform satisfactorily in this position are understood.

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Employee’s Signature                                                                                    Date

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Manager’s Signature                                                                                      Date

This form should be returned to the Human Resources Department for record retention in the employee’s personnel file.