Description
Purpose of Position: Lead organization in creating / maintaining world class quality system to exceed customer and regulatory requirements.Essential Functions:
- Leads / supports changes to Quality System procedures and practices.
- Administers programs for Compliance assessment and monitoring.
- Plans and directs activities of a complex nature to ensure the organization is compliant with its procedures, ISO standard, and FDA Quality System Regulation.
- Follows up with various team members on outstanding deliverables associated with maintaining the compliance and effectiveness of the quality system.
- Promote compliance to company procedures.
- Provide leadership to and be a capable resource.
Required Experience, Knowledge, Skills, Abilities or Education:
- Five or more years quality auditing, documentation, regulatory compliance and/or engineering experience.
- BS in science, engineering, manufacturing or technical discipline, CQA, or equivalent experience.
- Knowledge of medical quality systems.
- Knowledge of FDA 21 CFR Part 820 and ISO 13485.
- Knowledge of documentation systems.
- Willing to do the right thing regardless of the business pressures
- Demonstrated ability to improve processes and procedures
- Ability to work independently.
- Ability to manage multiple tasks utilizing organization and prioritization skills, self-motivated.
Please be in contact as soon as possible for this urgent position.
To find out more about Real please visit www.realstaffing.com