| Company: | GEHEALTHCARE |
|---|---|
| Job Role: | Quality Specialist. |
| Experience: | (2-3 years). |
| Vacancy: | 10+ |
| Qualification: | Bachelors degree or related skills. |
| Salary: | $ 99800/year. |
| Location: | Indianapolis - USA. |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
Job Description Summary
This position is responsible for supporting manufacturing and/or engineering processes in accordance with documented procedures and practices. This role supports the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices. The role involves hands-on work in the areas of new product introduction, process /equipment validation, training, CAPA, audits, and the QA support of manufacturing and distribution at the Noblesville, Indiana site.
Job Description
Roles and Responsibilities:
- Create a Quality culture by driving compliance activities.
- Ensure ongoing patient safety, regulatory compliance, and enable commercial delivery of GE Healthcare products by providing total quality management system process support in accordance with documented procedures and practices.
- Responsible for implementing and continuously improving the quality management system in the area of production and process controls. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
- Provide QA support for new product introductions
- Manage the site training program.
- Support the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms.
- Performs internal audits, supports external audits, and promotes product and process improvements through root cause analysis and CAPA.
- Support risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.
Required Qualifications:
- Bachelor's degree from an accredited university/college or a high school diploma / GED and minimum 6 years of experience in working in a regulated industry/ISO13485/ISO 9001.
- Proficient in Microsoft office applications.
Desired Characteristics:
- Experience in a Regulated Industry and/or demonstrated understanding of Medical Device quality management systems, regulations, and international standards including but not limited to FDA 21 CFR 820 and ISO 13485.
- Strong oral and written communication skills.
- Demonstrated ability to analyze and resolve problems.
How to Apply Click on the Below link, it will redirect you to source Page and apply there.
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