Senior Manager, Quality Systems

Join Brasseler and Be a Valued Team Member

Provides a safe and welcoming environment where team members can balance their lives and develop their careers. All people and experiences are valued and respected. Different perspectives are encouraged and lead to better results. This makes us who we are and enables us to be a world-class healthcare organization. All who join us are accountable to this charge.

Quality products sold with integrity has been the hallmark of Brasseler USA from the beginning. Brasseler USA's strong reputation of providing high quality, clinician endorsed and innovative dental and medical instrumentation nationally has spanned over 40 years. We have been offering a full-range of products made in the USA since 1976. Many of our products are manufactured at our headquarters in Savannah, GA.

Explore our career opportunities below to learn more.

Job Overview

The position manages all quality assurance activities for both the dental and medical companies. This is the key individual interpreting all applicable quality and regulatory requirements, providing and ensuring a compliant quality system, and managing the risks of our approach.

Key Responsibilities

• Directs efforts to establish, implement and maintain the Brasseler USA (BUSA) Quality System.
• Organizes and promotes company-wide quality improvements to ensure compliance with customer and regulatory requirements.
• Promotes awareness of regulatory compliance requirements and impact on BUSA operations.
• Develops and implements policies and procedures that drive quality responsibility and ownership throughout the organization.
• Analyzes and reports on the performance of the Quality System through internal audits and trend analysis as a basis for quality improvement.
• Performs the responsibilities of the Management Representative for the Quality Management System.
• Monitors and analyzes trends in key quality metrics. Reviews results with executive management. Makes recommendations for improvements.
• Promotes awareness of and compliance to the QMS.
• Responsible for quality system training program for BUSA company personnel.
• Manages the Supplier Quality, product complaint process, CAPA system, auditing program, validation plans, document control and document change activities.
• Drives definition, implementation, monitoring and communication of key Quality System metrics.
• Manages Quality staff to support mfg. operations, new product development and business expansion projects.
• Supports troubleshooting, root cause analysis, design control, supplier selection and evaluation, to address quality issues.
• Evaluates changes in regulatory requirements and make changes in the QMS to adapt to the new requirements.
• Cooperates with other managers in formulating and establishing company policies, operating procedures, and goals.
• Develop annual quality plans and objectives and ensure commitments are met and effective.
• Serve as technical expert of QS, Management Controls for the organization.
• Represent QS, Management Controls during regulatory inspections and notified body audit.
• Provide inspection support; inspection readiness, execution (front room and back room) and post inspection activities.
• Manages the budget for Quality Department.

Supervisory Responsibilities

Supervises / manages the Quality Engineering, Quality Systems and Operations Quality / QC personnel.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Experience

Preferred Education

Knowledge, Skills & Competencies

Travel / Working Conditions / Physical Demands

Benefits available include : Medical, Dental and Vision Coverage, 401K Plan with Company Match, Generous Time Off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.

Henry Schein is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.