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Quality & Reliability Engineer

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

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

Values: Integrity, Accountability,Teamwork, Innovation
Location: 

Plymouth, MN, US, 55442

City:  Plymouth
State:  MN
Country/Region:  US
Travel:  10% to 25%
Requisition ID:  64680
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Manufacturing Engineer, Engineer, Medical Device Engineer, Engineering, Quality

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