What are the responsibilities and job description for the Quality Engineer/Senior Quality Engineer position at ClinLab Solutions Group?
Quality Engineer/Senior Quality Engineer
Monroe, NC
Full time, permanent
- Set detailed guidelines on inspection and testing requirements
- Ensure products adhere to company and industry quality standards
- Develop inspection methods to analyze product quality
- Identify and lead CAPA and process improvement initiatives
- Develops, maintains and monitor measurement processes to ensure compliance to ISO and FDA regulations.
- Collaborate with supplier to investigate root cause and corrective actions when raw material or component deficiencies are detected
- Monitor and evaluate supplier process for compliance to purchase order and engineering requirements
- Deploy variation management tools and techniques at select suppliers to mitigate risk
- Audit suppliers and establish supplier quality requirements
- Reporting on supplier trends for management review and notification of identified trends to management for management review
- Design and implements methods for process control, process improvement, testing, and inspection
- Establish and maintains process flow diagrams, workplace layouts, FMEAs and standardize work instructions
- Other duties as assigned
Job Requirements
- Bachelor’s degree in engineering field or related field. Master’s degree in engineering is preferred.
- 3-7 years of experience in high volume regulated manufacturing industry in engineering field.
- Working experience of Six Sigma, lean and Quality Management Tools
- A broad knowledge of theory and principles of statistics and statistical process control
- Experience with Access Database, Excel and complaint handling software.
- In-depth knowledge of ISO13485, ISO14971, CFR part 820.
- Good understanding of medical device regulation, industry, and international standards.
- Strong computer skills in MS Office
- Ability to recognize and projects
- Ability to read and understand technical drawings and documents
- Working experience on CAD/SolidWorks
- Ability to work independently and take initiative
- Excellent communication, analytical, trouble-shooting and interpersonal skills
- ASQ Lead Auditor or equivalent training in auditing
- A team player as well as the ability to work independently