Quality & Reliability Engineer

Job Overview

The Quality & Reliability Engineer provides Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. This person will: 

• Assist in the coordination of continuous improvement processes for the quality system.
• Coordinate environmental monitoring activities for cleanroom and associated processes related to product quality.
• Responsible for planning and reporting on cleanroom disturbances and nonconformances related to environmental monitoring activities.
• Create nonconformance reports and CAPAs that may arise from cleanroom monitoring activities. Perform root cause analysis; determine corrective action and verification of effectiveness. Assure Corrective and Preventive Action plans are developed and executed.
• Create and modify current procedures and instructions.
• Develop and analyze statistical data and product specification to determine standards and to establish quality expectancy of products.
• Provide input into process validation for new equipment or processes.(IQ/OQ/PQ).
• Conduct training for personnel to ensure compliance to company procedures.
• Prepare and present technical and program information to team members and management.
• Perform internal audits within the company to ensure compliance to applicable regulatory and corporate standards/requirements and ISO.
• Communicate significant issues or developments identified during quality assurance audits and recommend process improvements to the Quality Manager.
• Prepare reports to communicate quality metrics.
• Maintain a working knowledge of government and industry quality assurance standards.
• Function as a resource for matters related to the Quality System.
• Ensure a high level of internal and external customer service.
   

TEGTA19

What your background should look like:

• 2-3 years experience or one year experience in a similar role in a medical device manufacturing environment
• Bachelors Degree in Science, Engineering or related subject
• Auditor Certification (ISO9000/ISO13485) and CQE Certification desirable
• Knowledge of job requirements in medical industry (FDA regulations).
• Knowledge of statistical tools, quality and reliability software
• Knowledge of spreadsheets, databases, Process Control & Monitoring (SPC)
• Experience in process improvement, Six Sigma, product and process qualification and validation
• Detailed knowledge of FDA, GMP, and ISO 13485
• Knowledge of measuring instruments, sampling plans.
• Well-developed writing skills.
• Proficient PC skills with word processing software.
• Proficiency with Microsoft Office Suite
• Knowledge in problem-solving techniques
• Effective organizational/time management skills applied in a fast-moving pressure filled environment
• Ability to work independently with little or no supervision, as well as in “team” settings
• Effective interpersonal skills and adeptness in working with culturally diverse employee population\
• Ability to effectively communicate verbally and in writing; proficiency in English required

Relocation assistance available to U.S.-based applicants. 

Competencies