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
Plymouth, MN, US, 55442
Nearest Major Market: Minneapolis
Job Segment:
Quality Engineer, Manufacturing Engineer, Engineer, Medical Device Engineer, Engineering, Quality