Job Details
Overview
We are looking for talented team members with drive, ideas, and a passion for helping our customers succeed to shape the future of S.I.N. 360. The Quality Management System and Compliance Manager will ensure our organization develops, implements, and maintains robust quality management systems and compliance programs. This role requires strong leadership skills, analytical thinking, and a comprehensive understanding of regulatory requirements in our industry.
Responsibilities
- Development and Implementation of QMS: Lead the design, development, and implementation of an effective Quality Management System (QMS) in accordance with industry standards and regulatory requirements.
- Compliance Oversight: Ensure compliance with relevant regulations, standards, and guidelines, including ISO, FDA, and other regulatory bodies applicable to our industry.
- Policy and Procedure Management: Establish and maintain policies, procedures, and documentation to support the QMS and compliance framework. Continuously review and update documentation to reflect changes in regulations or business processes.
- Training and Education: Develop and deliver training programs to ensure all employees understand their roles and responsibilities within the QMS and compliance framework. Provide ongoing education to keep staff informed of regulations and best practice changes.
- Risk Management: Identify potential risks to quality and compliance within the organization and develop strategies to mitigate these risks effectively.
- Internal Audits and Inspections: Plan and conduct internal audits to assess the effectiveness of the QMS and compliance programs. Coordinate external audits and inspections from regulatory authorities and other stakeholders.
- Continuous Improvement: Drive a culture of continuous improvement by analyzing data, identifying areas for enhancement, and implementing corrective and preventive actions to address deficiencies.
- Cross-functional collaboration: Collaborate with cross-functional teams, including manufacturing, research and development, regulatory affairs, and supply chain, to ensure alignment and integration of quality and compliance objectives.
- Vendor and Supplier Management: Evaluate and manage vendors and suppliers to ensure they meet quality and compliance requirements. Establish and maintain quality agreements and conduct supplier audits as needed.
- Reporting and Metrics: Generate reports and metrics to track key performance indicators related to quality and compliance. Present findings to senior management and make recommendations for improvement.
Minimum Qualifications:
- Bachelor's degree in a relevant field such as Quality Assurance, Regulatory Affairs, Engineering, or a related discipline.
- Minimum of 5 years of experience in quality management, compliance, or regulatory affairs within the Dental or Medical device industry.
- Strong understanding of relevant regulations and standards (21 CFR Part 820, ISO 13485, ISO 9001, FDA regulations).
- Proven experience leading the development and implementation of QMS and compliance programs.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
- Analytical mindset with the ability to identify trends, analyze data, and make data-driven decisions.
Desired Qualifications:
- Certification in quality management (Certified Quality Manager, Certified Quality Auditor) is a plus.
- The ability to listen actively and ask relevant, incisive questions and confident, independent thinking that communicates an analytic point-of-view to finance and business partners.
- Customer-focused mindset with the energy and desire to effectively collaborate and influence across a fast-growing organization.
S.I.N. 360 has a wonderful culture where people value their work and appreciate each other for their contributions. We develop our employees so they can grow professionally by preferring to be promoted from within. We have an open-door policy with direct access to executives; we want to hear your ideas and thoughts. Our company believes that to be productive long-term, we must have a genuine work-life balance. We understand that employees have families and entire lives outside of the office.
S.I.N. 360 is an Equal Opportunity Employer. We do not discriminate based on race, religion, color, sex, age, national origin, disability, or any other characteristic protected by applicable law.
S.I.N. 360 runs a comprehensive background check, credit check, and drug test as part of our offer process.
S.I.N. 360 offers:
- Insurance coverage (medical, dental, vision, life, and disability)
- Flexible paid time off
- Paid holidays
- 401(k) plan with company match