Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
Under the general supervision of the Quality Manager, perform electrical, mechanical, and visual inspections on in-process products and finished goods according to documented test and inspection methods to assure product safety and compliance to specifications, GMPs, and ISO requirements. Ensures the documentation process and production processes remain compliant. Identify in process defects, answer quality questions and review quality issues on the production floor.
Responsibilities:
- Review completed process travellers for accuracy and completeness and perform product documentation final release reviews.
- Perform In-Process and Final product inspections, makes an accept / reject decision, and creates a quality record following written procedures.
- Must possess the ability to perform various testing procedures and simple statistical analysis as related to sampling.
- Provides supplemental quality support to on-going projects.
- Assists with the investigation and closure of applicable Non-Conforming Material Reports.
- Conduct or assists in product/process/internal audits.
- Perform all Quality Control activities as required to ensure that production plans and objectives are completed.
- Coordinate with other departments to prioritize inspections and record reviews as appropriate.
- Assist with resolving quality problems within the inspection department, such as documentation or non-compliance issues.
Requirements:
- High School Diploma or GED required. Technical degree or professional certification preferred.
- At least one year experience performing electro-mechanical inspections in an FDA or ISO regulated environment.
- Basic familiarity with MS Office Products (Word, Excel, Outlook).
- Knowledge of mechanical and physical inspection techniques and tools (callipers, micrometres, depth gauges, etc.).
- Previous quality experience preferred.