QC Specialist
4 weeks ago
- Perform visual, dimensional, and functional inspections and/or testing across all components, subassemblies and finished medical device products using all applicable tools and equipment to ensure conformance with design specifications.
- Perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
- Ensuring all necessary samples are pulled and tested per procedures.
- Determine acceptability and/or identify defective raw materials and finished products following established procedures and specifications.
- Provide feedback on all quality related issues/results.
- Track equipment status using a spreadsheet, including making equipment labels, and scheduling/completion of equipment calibration/preventative maintenance.
- Perform testing, analysis and data reporting of test samples, utilizing basic analytical instrumentation/techniques such as pH, conductivity, etc.
- Draft procedures, work instructions, and reports in support of quality systems, manufacturing, and research/development.
- Initiate and/or draft non-conformance and out of specification reports.
- Support customer complaint investigations, as required.
- Perform all activities in compliance with cGMP requirements.
- Maintain and archive documentation in regulatory compliance for instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other product or project specific documentation.
- Additional projects and/or duties as assigned.
- Bachelor’s degree or higher is required in science or engineering.
- 5+ years of inspection and testing experience in GMP environment in medical device or pharmaceutical industries is required.
- Experience with proper usage of various metrology/inspection tools and equipment, hand eye coordination, and high manual dexterity.
- Experience with various inspection procedures, including the ability to contribute to and support the development of procedures.
- Strong communication skills and interpersonal relationship skills.
- Excellent written communication skills
- Ability to compose and document processes in a concise and easy for the end user to understand.
- Proficient computer skills specifically with Microsoft Excel and Word.
- Experience working in a regulated environment under ISO 9001, ISO 13485, or other GMP related industry.
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