Quality Assurance Sr. Manager

Dentsply Sirona, Inc•Manheim Township, PA

About The Position

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide. The Sr. QA Manager is responsible for the development, implementation, and continuous improvement of Quality System processes supporting Dentsply Sirona’s North America distribution network, including the Lancaster Distribution Center (LDC) and regional hub-and-spoke operations in the U.S. and Canada. This role ensures that all order-to-delivery processes, systems, and procedures comply with applicable medical device regulations, Good Distribution Practice (GDP), and corporate Quality Management System (QMS) requirements. The Sr. QA Manager leads and develops the North America Distribution QA team, fostering a culture of quality, accountability, and excellence. Manages internal and supplier audit programs, facilitates regulatory and corporate inspections, and oversees quality performance of 3PL partners to ensure full compliance with Dentsply Sirona policies and regulatory requirements. The Sr. QA Manager acts as the primary QA contact for North America distribution activities and collaborates closely with global QA, Supply Chain, Commercial and Regulatory Affairs teams to ensure alignment and standardization of quality processes across regions. The Sr. QA Manager acts as a working leader who is willing to roll up their sleeves to address operational challenges, model accountability, and drive continous improvement alongside the team.

Requirements

Bachelors Degree in Science, related technical field or equivalent.
Minimum 10 years of Quality Assurance and/or Regulatory Affairs experience in the medical device or pharmaceutical industry, with at least 5 years in a leadership or supervisory capacity.
Demonstrated experience with distribution, logistics, or supply-chain quality systems (GDP, import/export compliance, warehouse operations).
Proven ability to host and manage regulatory inspections (e.g., FDA, Health Canada, or other health authorities) and corporate quality audits.
Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, MDSAP, and related regulatory frameworks.
Experience collaborating cross-functionally with Regulatory Affairs, Supply Chain, and Operations to drive compliance and continuous improvement.
Demonstrated success in achieving/exceeding sales results
Ability to work well within a team environment
Results oriented and highly self-motivated
Able to strike a proper balance between catalyst for change and team player
Sound risk management decision-making
Critical and analytical problem-solving skills
Strong ability to multi-task and juggle various projects effectively
Adaptability to changing demands and conditions
Excellent organizational and time management skills
Strong interpersonal skills
Strong written and verbal communication skills
Strong computer skills
Knowledge/experience in an ISO setting
Manufacturing experience
Positive “can do” professional attitude.

Nice To Haves

Advanced degree or professional certification in Quality or Regulatory Affairs (e.g., ASQ CQA, RAC, Six Sigma Green Belt) preferred

Responsibilities

Establishes, maintains, and continuously improves the regional Quality Management System (QMS) to ensure compliance with FDA 21 CFR 820, ISO 13485, and any other applicable regulatory and corporate requirements.
Leads day-to-day quality system activities across North America distribution and commercial operations in alignment with Dentsply Sirona policies and international standards.
Ensures consistent implementation and monitoring of QMS processes, including CAPA, change control, complaint handling, and nonconformance management.
Maintains visibility of upcoming regulatory or operational changes that could impact compliance or process performance, proactively mitigating associated risks.
Establish, Monitor, analyze, and report on key performance indicators (KPIs) and quality metrics to identify trends, drive continuous improvement, and support strategic decision-making.
Supports the rollout and maintenance of the harmonized global QMS across the company’s distribution network.
Plans and conducts (or coordinates) internal self-assessments and audits to verify adherence to FDA, ISO, and corporate standards.
Reviews audit findings and ensures timely implementation of effective corrective and preventive actions.
Coordinates preparation and follow-up for FDA and third-party inspections.
Manages FDA establishment registration, device listing, and annual renewals to ensure regulatory compliance.
Develops, implements, and monitors training programs to ensure compliance with regulatory and internal QMS requirements.
Establishes and tracks training effectiveness metrics to verify employee competence in SOPs, GMPs, and job-related quality activities.
Manages and develops QA staff through clear goal setting, performance management, and ongoing feedback.
Ensures job descriptions and individual performance objectives remain current and aligned with evolving business needs.
Promotes employee engagement and professional growth through delegation, coaching, and individual development planning.
Recruits, trains, and retains qualified QA professionals to support current and future business requirements.
Fosters a culture of accountability, collaboration, and continuous improvement within the QA organization.
Conducts or coordinates annual GMP and Quality Awareness training for new and existing employees.
Partners cross-functionally with Operations, Sales, Customer Service, and Manufacturing to identify trends, implement corrective actions, and reduce quality deviations.
Communicates quality alerts, product holds, delays, and recalls promptly and in accordance with established procedures.
Drives continuous improvement initiatives to strengthen compliance, reduce risk, and enhance quality system efficiency.
Collaborates with global and regional QA/RA teams on initiatives to ensure alignment across the enterprise.
Performs other duties as assigned to support quality and regulatory compliance objectives