Description
Summary of Essential Job Functions- CAPA activities
- developing/writing SOPs
- manufacturing process development
- six sigma experience is a plius
- Facilitates training efforts by managing records and ensuring timely completion of training requirements
- Assists with document control activities by managing site controlled documents and records
- Supports efforts related to non-conforming material reporting, process deviations, and corrective/preventive actions
- Participates in the review of production travelers for release of subassemblies and/or finished products
- Supports the administration and documentation of lot release testing activities
- Serve as part of the audit team for external and internal audits
- Participates in complaint investigations
- Collects/analyzes/trends quality data (support of Quality meetings)
- Participates in process improvement initiatives individually and in teams to accomplish specific tasks related to Quality goals and objectives
Minimum Requirements
- High School Diploma
- 3 years' experience in quality control function preferred
- 1 year experience in medical industry preferred
- Knowledge of quality systems, compliance, and testing protocols
- Understanding of cGMP and GDP principles
- Good written and verbal communications
- experience with Oracle and Agile is a plus
- Proficiency in Microsoft Office applications (Word, Excel) and data entry
- Must be able work occasional overtime with sufficient notice
- Superior organizational skills
- Must be flexible to changing priorities and able to multi-task different projects
Preferred Attributes
- College degree (Engineering, Math, Sciences)
- ASQ Certifications (CQE, CQA, CQI, etc)
- ISO 13485 Lead Auditor Certification (RABQSA)