Director of Quality and Regulatory Affairs
hace 6 días
Aquaneer Technologies is seeking a highly skilled Director of Quality and Regulatory Affairs to lead our quality systems and ensure compliance with customer requirements and supplier capabilities. As a key member of our team, you will be responsible for facilitating the systems required to reach and maintain ISO, GLP, GMP, and Quality compliance.
Key Responsibilities- Coordinate ISO, customer audits, and FDA inspections
- Monitor and report KPIs related to client objectives
- Analyze department expenses to identify areas for reduction or improvement
- Establish plans and operate within an annual financial budget
- Facilitate and report on the status of Corporate Quality Metrics
- Develop, implement, and maintain quality systems, policies, and procedures
- Support and improve company Quality Systems by creating a quality culture and providing ongoing education on compliance activities
- Implement continuous improvement processes across all areas of business
- Manage analysis and records of customer complaints, NMRs, RMSs, etc.
- Work with IT to verify and manage software programs affecting the QMS
- Manage the client's risk management process to ensure the correct risk assessment
- ASQ (American Society for Quality) and/or ISO certification as an Auditor, Biomedical Auditor, or Six-sigma Green Belt
- Bachelor's degree in business, science, or a technical field
- Minimum of 5+ years in regulatory and quality
- Ability to interpret technical instructions and deal with abstract and concrete variables
- Able to multitask, prioritize, and meet deadlines with strong organizational and follow-up skills
- Advanced computer skills, including statistical/data analysis, report writing skills, Microsoft Office, Excel, and the like
- ASQ (American Society for Quality) and/or ISO certification as a CMQ/OE, Six-sigma Black Belt, and/or Quality Engineer (CQE)
- Master's degree in a business, science, or a technical field with ten or more years of relevant experience
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Regularly required to stand, sit, walk, use hands to input, able to hear and talk
- Position requires data entry and regular use of computer/keyboard/mouse for extended periods of time
- Work demands concerted mental attention
- Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus
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