The Quality Assurance Engineer will update, maintain and enforce the quality system beginning from the ground level. This person will work with Pulpdent’s regulatory team, manufacturing team, and product development team to improve Pulpdent’s current systems and create systems for the future.
Support ISO 13485 certification and compliance with FDA, European, Canadian, and other regulations by leading the development, implementation and maintenance of the quality system.
Create, update, or maintain procedures to ensure the smooth functioning of the QMS.
Support manufacturing through equipment qualifications, process validations, and process improvements.
Oversee the establishment and maintenance of engineering activities including calibration and preventive maintenance.
Assist with and oversee data collection and analysis activities.
Conduct inspections for quality product/component/process.
Develop test protocols and/or inspection procedures.
Participate in the internal quality audit program.
Prepare Nonconforming Reports (NCRs) as needed, contribute to dispositioning decisions and approval.
Assist in tracking and obtaining information of NCRs to assure adequate completion
Oversee the processing of corrective and preventive action plans. Performing effective root cause analysis. Assist in tracking CAPAs to closure.
Assist with risk management activities.
Support R&D on new product development programs by ensuring appropriate controls are in place.
Suggest alternative methods and procedures in addressing challenges, proposing new ideas and offering improvements while still meeting quality requirements.
Other duties as assigned.
Work Environment & Physical Demands
Ability to sit for long periods of time.
Other duties as assigned
Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
PULPDENT® is an equal opportunity employer. We employ a diverse workforce and encourage people of all backgrounds to apply for employment.
Required Education & Experience
3-5 years relevant experience in quality assurance.
Bachelors in a scientific field.
Strong understanding of quality systems regulations, good manufacturing practices for medical devices, ISO 13485, FDA 21CFR PART820, EU Medical Device Regulations and Canadian Medical Device Regulation.
Familiarity with manufacturing facilities a plus.
Additional Salary Information: Commensurate with experience
About Pulpdent Corporation
Founded in 1947, PULPDENT® Corporation is a family-owned dental research and manufacturing company that is leading the way in bioactive dental materials. PULPDENT®’s corporate headquarters and manufacturing facility are located in Watertown, MA and PULPDENT® products are sold worldwide. PULPDENT® is known for its family-friendly environment and the longevity of its employees. To learn more about PULPDENT® visit www.pulpdent.com.