Quality Assurance Manager
2 weeks ago
As a Quality Assurance Manager at Dental Technologies Inc., you will be responsible for leading quality assurance activities for medical device, over-the-counter, and prescription drug products. This role requires a strong understanding of regulatory requirements and the ability to interpret and implement them effectively.
Key Responsibilities:
- Interpret and implement regulatory requirements, including Code of Federal Regulations (21 CFR parts 211 and 820) and ISO 13485.
- Manage the Corrective and Preventive Action (CAPA) program, investigating issues and determining strategies for corrections and preventive actions.
- Conduct Out of Specification (OOS) investigations and support laboratory OOS investigations.
- Review and support investigation activities for customer complaints.
- Manage Quality Assurance Inspectors and ensure quality requirements are met for inspection of incoming components and filling activities.
- Provide support on quality assignments relating to internal procedures, training, and interpretation of existing and new international regulations.
- Manage validation activities for filling processes to ensure they consistently produce product that meets quality specifications and requirements.
- Review product design, label, or other changes for impact on quality.
- Review product labeling and claims for compliance to applicable regulations.
- Comply with cGMP, EHS guidelines, and all working procedures assigned to the position.
Requirements:
- Bachelor's degree in a science-related discipline, with 5 years of relevant experience.
- Master's degree preferred, with Regulatory Affairs Professional certification.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to calculate figures and amounts, such as proportions and percentages.
- Ability to carry out instructions furnished in written, verbal, or diagram form.
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 knowledge, skills, and experience.
EEO Statement:
Dental Technologies Inc. is proud to be an equal opportunity employer.
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