Director Quality Assurance & Regulatory Affairs
Classes I, II, and III
The Director Quality Assurance & Regulatory Affairs is critical in ensuring that a company’s products and operations meet regulatory requirements and quality standards. This position requires experience in pharmaceuticals, medical devices, or biotechnology industries.
Director Quality Assurance & Regulatory Affairs Summary
The Director of Quality Assurance and Regulatory Affairs is responsible for leading and managing all aspects of quality control, quality assurance, and regulatory compliance within the organization. This role is essential in maintaining and improving product quality, ensuring compliance with relevant laws and regulations, and safeguarding the company’s reputation.
The Director Quality Assurance & Regulatory Affairs is an SME and management position.
- A minimum of 8-10 years of experience in quality and regulatory affairs of a medical device manufacturer, an ISO 13485 certified operation, with
- At least 3-5 years in a quality management or leadership role are necessary to be successful as the Director of Quality Assurance and Regulatory Affairs.
If this describes your experience, please see the Director of Quality Assurance and Regulatory Affairs job description.
Director Quality Assurance & Regulatory Affairs Job Description
The Director of Quality Assurance and Regulatory Affairs is responsible for leading and managing all aspects of quality control, quality assurance, and regulatory compliance within the organization. This role is essential in maintaining and improving product quality, ensuring compliance with relevant laws and regulations, and safeguarding the company’s reputation.
Key Responsibilities:
- Quality Management System (QMS) Leadership:
- Develop, implement, and maintain an effective QMS aligned with relevant regulations (e.g., FDA, ISO, etc.) to ensure compliance across all product life cycle stages.
- Continuously assess the QMS’s effectiveness, identify improvement areas, and lead initiatives to enhance processes and procedures.
- Regulatory Compliance:
- Stay abreast of evolving regulations, standards, and guidelines related to medical devices and quality management.
- Act as the primary point of contact for regulatory agencies during audits and inspections.
- Collaborate with cross-functional teams to address any quality-related issues and implement corrective actions.
- Quality Assurance:
- Establish and monitor quality metrics and Key Performance Indicators (KPIs) to track product performance and process efficiency.
- Ensure that all manufacturing processes and materials meet the required quality standards.
- Oversee the review and approval of product and process documentation, including validation protocols, technical files, and risk assessments.
- Risk Management:
- Lead risk management activities, including risk assessment, analysis, and mitigation strategies for product development and post-market surveillance.
- Foster a culture of risk awareness within the organization, encouraging proactive risk identification and management.
- Supplier Quality Management:
- Collaborate with the supply chain team to establish and maintain a robust supplier quality management program.
- Conduct supplier audits, evaluate supplier capabilities, and drive continuous improvement in supplier performance.
- Training and Development:
- Provide training and guidance to employees on quality-related topics, including regulatory requirements and best practices.
- Support the professional development of the quality team, fostering a culture of continuous learning and growth.
- Post-Market Surveillance:
- If necessary, oversee the post-market surveillance process, including complaint handling, adverse event reporting, and product recalls.
- Analyze post-market data to identify trends and drive product safety and performance improvements.
- Cross-Functional Collaboration:
- Work closely with R&D, manufacturing, engineering, and other departments to integrate quality considerations throughout the product development and manufacturing processes.
Qualifications and Experience:
- Bachelor or advanced degree in a relevant scientific or engineering discipline.
- At least 8-10 years of experience in the medical device industry, with at least 3-5 years in a quality management or leadership role.
- In-depth knowledge of medical device regulations, including FDA QSR, ISO 13485, and other relevant standards.
- Experience with risk management methodologies, such as ISO 14971.
- Proven track record of successful interactions with regulatory agencies during audits and inspections.
- Strong leadership and communication skills, with the ability to inspire and motivate cross-functional teams.
- Analytical mindset with a focus on data-driven decision-making.
- Professional certifications in quality management (e.g., ASQ certifications) are desirable but optional.
As the Director of Quality, you will be an integral part of the organization’s success by ensuring the quality and compliance of our medical devices, ultimately contributing to the well-being of patients and the company’s success in the healthcare market.
Location: Ohio
Director Quality Assurance & Regulatory Affairs works in Cleveland
Compensation
The compensation package includes a competitive base salary, an annual bonus, profit sharing, and benefits.
Our client offers exceptional advancement potential for an ambitious person.
Company information
The company has excellent brand recognition, a reputation for quality products, and a commitment to exceptional customer experiences. Their products are distributed globally.
The timeframe to fill this search is as-soon-as-possible.
The Director Quality Assurance & Regulatory Affairs is pivotal in ensuring a company’s products meet quality standards and are compliant with regulations, ultimately contributing to the company’s success and reputation.
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