What are the responsibilities and job description for the Quality Manager position at R&D Partners?
Are you ready to lead quality excellence in the medical device world and shape the systems that keep innovation safe, compliant, and industry leading?
R&D Partners is seeking a talented Quality Manager to join a dynamic team in the medical device industry. This role focuses on developing, implementing, and maintaining robust Quality Management Systems (QMS) and compliance programs. The ideal candidate will have strong leadership skills, analytical thinking, and a comprehensive understanding of regulatory requirements.
Applicants must have legal authorization to work in the United States.
Responsibilities:
- Development and Implementation of QMS: Lead the design, development, and implementation of an effective QMS aligned with industry standards and regulatory requirements.
- Compliance Oversight: Ensure adherence to relevant regulations, including ISO standards, FDA guidelines, and other applicable regulatory bodies.
- Continuous Improvement: Foster a culture of continuous improvement by analyzing data, identifying areas for enhancement, and implementing corrective and preventive actions.
- Cross-Functional Collaboration: Work closely with manufacturing, R&D, regulatory affairs, and supply chain teams to align quality and compliance objectives.
- Policy and Procedure Management: Establish and maintain policies, procedures, and documentation to support the QMS and compliance framework.
- Training and Education: Develop and deliver training programs to ensure employees understand their roles within the QMS and compliance framework.
- Risk Management: Identify and mitigate risks to quality and compliance within the organization.
- Vendor and Supplier Management: Evaluate and manage vendors and suppliers to ensure they meet quality and compliance requirements, including conducting supplier audits.
Key Skills and Requirements:
Minimum Qualifications:
- Bachelor's degree in Quality Assurance, Regulatory Affairs, Engineering, or a related field.
- Minimum of 5 years of experience in quality management, compliance, or regulatory affairs within the dental or medical device industry.
- Strong knowledge of relevant regulations and standards (e.g., 21 CFR Part 820, ISO 13485, ISO 9001, FDA regulations).
- Proven experience leading QMS development and compliance programs.
- Excellent communication and interpersonal skills for collaboration across all organizational levels.
- Analytical mindset with the ability to identify trends and make data-driven decisions.
Desired Qualifications:
- Previous experience in medical devices, pharmaceuticals, or the dental industry.
- Project management experience in quality or regulatory initiatives.
- Certification in quality management (e.g., Certified Quality Manager, Certified Quality Auditor) is a plus.
- Customer-focused mindset with the ability to collaborate and influence effectively in a fast-growing organization.
For more information, please contact Toby Shelton.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
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