What are the responsibilities and job description for the Senior Manager, Quality Systems position at BioTalent?
Company Overview
Part of a global Fortune 500 organization, this Medical Device company is a leading manufacturer of innovative dental and medical instrumentation. They are specialized in offering a comprehensive range of high-quality instruments and related procedural solutions designed to meet the needs of dental professionals and clinicians. With a strong reputation for precision, reliability, and customer-focused service, they support endodontics, periodontics, oral surgery, and restorative dentistry.
Position Overview
The Senior Manager, Quality Systems is responsible for overseeing all quality assurance activities across the organization’s dental and medical product lines. This leader ensures compliance with applicable regulatory requirements and maintains a robust Quality Management System (QMS), acting as the primary authority on quality standards and practices.
Job Responsibilities
- Lead the development and maintenance of the company’s Quality System.
- Drive continuous quality improvement and regulatory compliance across all departments.
- Develop and implement quality policies, procedures, and training programs.
- Analyze quality system performance through audits and data trends; report to leadership.
- Oversee supplier quality, complaint handling, CAPA, audits, validations, and document control.
- Serve as the Management Representative for the QMS during audits and inspections.
- Collaborate with leadership to integrate quality into company policies and business goals.
- Manage the Quality team and budget, supporting manufacturing, product development, and growth initiatives.
- Monitor regulatory changes and adapt internal processes accordingly.
- Represent the Quality function during inspections and audits by regulatory bodies.
Background Requirements
- Bachelor's degree in a scientific or technical discipline required.
- Minimum 5 years of experience in Medical Device Quality Assurance
- At least 5 years of management experience preferred.
- Strong knowledge of FDA regulations, ISO 13485, MDSAP, and EU MDR.
- Proven leadership, communication, and analytical skills.
- Experience interacting with regulatory bodies and managing complex projects.
- Proficient with Microsoft Office and capable of multitasking in a dynamic environment.
- Ability to travel up to 10%.
Salary : $120,000 - $160,000
