Quality Assurance Regulatory Affairs Manager

Take on this high-impact leadership opportunity where your expertise will directly influence operational excellence, product quality, customer satisfaction, and continued company growth. You’ll work alongside collaborative leadership teams, drive meaningful process improvements, and play a critical role in supporting innovative products used by dental professionals worldwide. Earn up to $150,000/year and outstanding company benefits while working for a supportive and employee-focused company culture!

DentalEZ, one of the fastest growing dental equipment manufacturers in the country, is seeking a Quality and Regulatory Affairs Manager in Lancaster, PA.

Qualifications:

• 4-year degree from an accredited university
• ASC CQA and/or CQE certification
• Familiarity with FDA regulatory policies and procedures
• Managerial experience in a quality or regulatory team

Why DentalEZ is the Perfect Place for a Quality and Regulatory Affairs Manager in Lancaster, PA:

• Opportunity for Impact: DENTALEZ offers a very collaborative work environment in a climate-controlled facility where you will be able to take their processes and production capabilities to the next level.
• Total Competitive Compensation: Earn between $100,000-150,000/year depending on experience
• Great Benefits: Including health, dental, vision, 401(k) with a 5% company match on your 7% contribution, Generous PTO (11 paid holidays, 15 days of paid time off), flexible spending account, life insurance, long and short-term disability, AD&D, employee assistance program, other optional insurance plans, and more!
• Company Culture: Every employee is highly valued and able to make real changes within the organization. At DENTALEZ, you can guarantee that you will be heard.

Duties and Responsibilities:

• Subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to sell product globally.
• Manages and oversees the Quality Management System; ensure best and most current practices are leveraged company wide.
• Collaborates internally and externally to determine customer requirements and ensure they are met.
• Partners with critical suppliers to maintain the highest rate of supplier performance and compliance.
• Establishment and use of metrics to monitor the suitability and effectiveness of the QMS.
• Develops, maintains and follows ISO procedures and GMP requirements pertaining to medical devices.
• Responsible for managing the RMA, QC Inspection, document control personnel & processes, Acceptance Activities, Calibration Process, Quality Management System (QMS) Training Process, Material Review Board, and Quality Engineering activities.
• Advises personnel and project teams on quality system and regulatory requirements, coordinates and presents regulatory information, and negotiates with and influences management and colleagues to ensure requirements are met.
• Ensures that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures.
• Coordinate with external consulting resources as needed.
• Manage the Internal Audit, CAPA program and Supplier CAPA program.
• Work with process owners of CAPAs and internal audit findings and ensure appropriate corrective actions plans are implemented and verified for effectiveness.
• Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended structure of the Quality System.
• Familiarity with and implements Six Sigma, lean manufacturing, ISO 9001, and similar principles or standards.
• Assesses project risks and adjusts as necessary to ensure proper regulatory compliance.
• Develops and implements regulatory strategies regarding the preparation of new products.
• Oversees audits, inspections, and product recalls. Serves as the primary point of contact for technical product development teams.

About the Company: Our mission is to provide real, everyday solutions to the challenges of dentistry by addressing the needs of patients and oral health professionals. DENTALEZ® is a dental supply company committed to providing state-of-the-art dental practice solutions for unlimited interconnectivity, choice, and control. A true dental pioneer, the company stands as an indispensable industry staple with over 100 years of experience in dental equipment. DENTALEZ provides real-life solutions for everyday challenges in oral healthcare through a unique union of advanced technical expertise and rich practical experience. With unwavering top-level customer service and support, the company has securely established itself as a trusted supply partner in dentistry. DENTALEZ has a proven history of providing tried-and-true dental products and equipment and continues to manufacture a full line of technologically-advanced front-to-back office solutions from well-known brands including Star®, Ramvac®, Forest®, Nevin™, and Columbia

DENTALEZ® is an Equal Opportunity Employer, including disability and veteran status.