Senior Manager, Quality Systems

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.

WORK EXPERIENCE:

• Minimum of 5 years Medical Device Regulatory Affairs experience; or equivalent combination of education and experience. Must extensive experience with FDA medical device regulations, ISO 13485, MDSAP, EUMDD/MDR requirements.

• 7 Years, experience in management is preferred

PREFERRED EDUCATION:

• Bachelor's degree (B.S.) from four-year College or university

KNOWLEDGE, SKILLS & COMPETENCIES:

• Attract, retain, motivate, coach, and develop team members for high performance

• Ability to lead and manage complex projects

• Excellent decision making skills

• Excellent analysis and problem solving skills

• Excellent organizational skills and extreme attention to detail

• Demonstrated success in negotiations with regulatory and/or notified bodies and other participants

• Excellent written and verbal communication skills (including interaction with both internal personnel and external organizations such as regulatory agencies and customers.

• Ability to read, analyze, and interpret technical journals, legal documents, test reports, clinical and medical terminology, technical product information, and complex documents

• Strong PC computer skills with everyday experience working with Microsoft products.

• Multi-tasking is essential for this position. A high energy level and comfortability performing projects in conjunction with day-to-day activities.

• Ability to speak effectively before groups of employees, management, and agency representatives.

• Knowledge of quality and regulatory standards, include ISO.

TRAVEL / WORKING CONDITIONS / PHYSICAL DEMANDS:

• Travel - typically not more than 10%

• Position typically works in an office environment whether on site or remote where environmental conditions are stable

• This position will typically

• While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 pounds