HuFriedyGroup is the dental industry leader in infection prevention solutions, premium instrumentation, and service and support programs that help dental professionals be the best in practice. As the dental division of Cantel, HuFriedyGroup encompasses a vast array of brands and products, integrated together to deliver full service and support - a complete circle of protection - to dental practices around the globe. We are dedicated to employee engagement and development, diversity and inclusion, wellness, and social responsibility. Our core values and well-defined culture are evident in daily life at HuFriedyGroup and continue to shape the success of our business.
About the role
The Sr. Quality Engineer supports Manufacturing Operations and R&D by resolving quality-related issues, improving product quality, investigating customer complaints and reducing costs. Utilize the Correction and Preventive Action system to pursue continuous improvement of the Quality System and products. Assist with supplier support and play an active role in cost reduction projects that support Lean initiatives. #CB
What you will do
Manage non-conformance records for defects and issues associated with manufacturing events.
Investigate/analyze in-house and field failures (returns) and monitor quality trends.
Propose and implement possible solutions/improvements utilizing the Corrective and Preventive Action (CAPA) system.
Participate and lead root cause investigations and analysis of customer complaints.
Develops and evaluate statistical sampling plans associated with incoming inspection and product release.
Leads / participates in the preparation of risk assessments associated with product quality issues.
Review and approve disposition for Nonconforming Product and participate in Material Review Board (MRB) team.
Support and champions efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
Participate and lead audit readiness activities by applying knowledge of ISO13485 and 21CFR Part 820 regulations.
Develop, monitor and refine quality performance process; partner with key stakeholders to track and trend Key Performance Indicators.
Support all functional departments to ensure compliance with the Quality System and continuous improvement efforts of the Quality System.
Key participant and leads CAPA Review Board.
Ensure adequate supplier control plans are implemented, documented, and maintained.
Approve documentation and change requests related to products and manufacturing processes.
Interface with personnel from all areas of the company to foster improved quality and reduced cost.
When applicable, provide guidance to QA Inspectors and QA Technicians as defined by QA Manager.
Provide guidance and conduct training in aspects of the company quality system requirements as they pertain to manufacturing quality and supplier quality.
Other related duties as assigned.
What we are looking for
B.S. Degree required in Engineering, or equivalent technical discipline.
A minimum of 5 years with relevant experience in a regulated environment (Medical Device, Pharmaceutical, or Consumer), specifically in a manufacturing support role required.
Note: Experience with chemical or biological indicators and / or medical office equipment preferred.
Experience with Non-conformances and CAPA records processing is required.
Experience with product and process risk analysis/FMEA development is required.
Strong background in process validation and equipment qualification required.
Highly knowledgeable with ISO 13485:2016 and 21CFR Part 820 requirements required.
Experience with internal and external audits is required.
Ability to define and understand Design of Experiments and Sampling Plans required.
Effective ability to work independently as well with a cross-functional team across teams is required.