Katalyst Healthcares and Life Sciences
Responsibilities:
- Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiates Change Controls and Document Change Requests to update procedures and processes.
- Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
- ssists with monitoring and assessing quality system metrics to ensure maintained compliance.
- cts as a lead auditor for division internal audit program.
- ssists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
- Supports or leads continuous improvement initiatives for quality management system processes.
- ssists with regulatory activities.
- Bachelor's Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
- Master's Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).
- Proficiency in Microsoft office.
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge.
- Internal auditor experience and/or training.
- Must be detail oriented and accurate.
- bility to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
- bility to work across matrix organizations and external consultants.
- ble to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.