Does being part of a company with proven success on a global scale excite you?
Do you want an opportunity where your skills truly make an impact?
Are you passionate about leadership?
If the answers to these questions were yes; then this Director Quality Assurance and Regulatory Affairs opportunity with an outstanding Medical Device organisation in Illinois might be the change you need.
Summary
Oversees product design, performance, and processes to meet company quality standards. Works closely with manufacturing, engineering, support teams, suppliers, and customers to achieve quality objectives.
Ensures compliance with regulatory standards and readiness for inspections. Manages internal and external audits and maintains departmental policies, procedures, training programs, and quality documentation, including CAPAs.
Key Responsibilities :
- Act as the main contact for ISO standards, overseeing audits and implementing necessary systems.
- Maintain and enhance the Quality Management System to align with internal, customer, ISO, and FDA requirements.
- Oversee adherence to FDA regulations, including cGMP, and evaluate complaints for FDA reporting.
- Plan, conduct, and supervise internal audits to ensure compliance with quality standards.
- Train and support staff in achieving quality objectives and maintaining standards.
- Manage the inspection processes for incoming, in-process, and final products to meet quality requirements.
- Update and enforce quality management procedures, including record-keeping and policy adherence.
- Liaise with suppliers, OEMs, and the parent company regarding certifications, product performance, and quality issues.
- Oversee CAPA, validation, technical files, and complaint management to address quality issues.
- Independently review risk management studies, manage document control, and ensure compliance with regulatory standards.
Qualifications :
- In-depth understanding of regulatory and quality practices across the product lifecycle.
- Over 8 years of experience in quality assurance and regulatory roles.
- Strong knowledge of ISO 13485 and experience working with regulatory bodies like UL, ISO, and FDA.
- Ability to interpret engineering drawings and documentation, with proficiency in algebra, statistics, and probability for data analysis.
- ASQ certification is preferred.
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