Quality Engineer (Pharmaceutical)

Job Description

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.