Job description
Responsibilities:
- Direct and improve validation activities for the facility, including maintenance of the Validation Master Plan
- Perform, evaluate and analyze validation protocols and associated data for compliance with site procedures and ISO guidelines.
- Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with Quality System and regulatory requirements.
- Actively partner with Manufacturing and supporting departments on special projects to create and revise qualification and validation protocols, studies, or other improvement projects
- Facilitate supplier visits related to validation, calibration, preventive and corrective maintenance as required.
- Support the Facilities department to capture Quality related and validation activities.
- Participate in and support change control activities for documents and manufacturing processes.
- Oversee the execution of the site's preventive maintenance and calibration program, ensuring that OOTs are promptly resolved, and risk assessments performed.
- Investigate, analyze, and correct process non-conformances (internal, external and systemic issues)
- Actively seek, create, and implement projects for quality improvement.
- Collect, analyze, and present Quality data.
- Define, drive, and execute process and product improvement plans and ensure their effectiveness.
- Participate as internal auditor and participate in external audits.
- Has a proactive and process-driven approach to problem solving.
- Able to define problems, collect data, establish facts, and draw valid conclusions.
- Investigate organic material failures with the support of technical team.
- Eliminate root causes through effective corrective actions.
- Other duties may be assigned, as required.
- Travel requirement: 0-10%
- Bachelor of Science in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or BS with other demonstrated equivalent work experience in the Quality Systems area pertaining to a scientific industry.
- 2-5 years' experience in the Quality Assurance field required.
- Strong computer skills (MS Word, MS Excel, MS PowerPoint)
- Knowledge of Quality Assurance and/or Quality Systems, including standards such as ISO 13485 Medical Devices Quality Management System
- Knowledge of Operations and manufacturing processes
- Familiar with enterprise software systems including Agile, TrackWise , SAP-LMS
- Knowledge of statistical data analysis methods and tools (e.g., JMP, Minitab)
- Able to motivate and positively influence peers.
- Able to resolve rapidly common or complex inquiries or complaints from internal and/or external customers and regulatory agencies.
- Able to effectively present information to groups of employees, site leadership, and customers
- Able to read, analyze, and interpret common scientific data and QMS standards.
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