Job Description
Job Title: Quality Assurance Engineer
Department: Quality
Reports To: Director of Regulatory Affairs & Quality
Summary
Leads quality assurance activities for medical device, over-the-counter, and prescription drug products.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Interprets Code of Federal Regulations (21 CFR parts 211 and 820), ISO 13485, and other regulatory requirements and updates internal procedures to be compliant.
• Manages the Corrective and Preventive Action (CAPA) program by investigating issues that have or may cause a product nonconformance and require actions to prevent reoccurrence. Determines the strategy for corrections, corrective actions, and preventive actions. Implements or oversees the implementation of these resolutions. Verifies implementation and effectiveness of actions taken. Documents all activities of the CAPA process in CAPA reports.
• Conducts Out of Specification (OOS) investigations for nonconformances related to DTI’s manufacturing and filling operations. Where applicable, requests investigations and/or corrective actions from DTI’s suppliers. Supports and reviews laboratory OOS investigations to provide independent quality oversight of laboratory testing.
• Reviews and supports investigation activities for the resolution of customer complaints.
• Provides support on quality assignments relating to the development of internal procedures, training, and interpretation of existing and new international regulations.
• Reviews product design, label or other changes for impact on quality.
• Reviews product labeling and claims for compliance to applicable regulations.
• Complies with cGMP, EHS guidelines, and all working procedures assigned to the position.
• Performs other tasks, as assigned.
Supervisory Responsibilities
None.
Competencies
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and/or Experience
Bachelor's degree (science-related discipline preferred) with 2 years relevant experience. Master's degree is preferred. Regulatory Affairs Professional certification preferred.
Language Skills
Able to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Mathematical Skills
Ability to calculate figures and amounts such as proportions and percentages.
Reasoning Ability
Ability to carry out instructions furnished in written, verbal, or diagram form.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Pay Range
The Quality Assurance Manager is an exempt position that is paid semimonthly. Pay rate will be dependent on a number of factors including but not limited to knowledge, skills, and experience.
EEO Statement
Dental Technologies Inc. is proud to be an equal opportunity employer.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Company DescriptionDental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at:
Dental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at:
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