Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Quality Assurance/Regulatory Affairs Specialist I: Molecular Diagnostic Products
Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI has developed technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products. We are a small, growing company that offers a relaxed but challenging work environment.
POSITION TITLE: Quality Assurance/Regulatory Affairs Specialist I
BENEFITS:
How to apply: by Email/ No Phone inquiries accepted
A cover letter is required.
GENERAL SUMMARY:
The Quality Assurance/Regulatory Affairs Specialist I is responsible for activities involving quality assurance and compliance with applicable regulatory requirements. Under the supervision of the Manager of QA/RA, the QA/RA Specialist I is responsible for the maintenance of policies, and management of procedures, that ensure quality compliance to MMQCI’s Quality System, based on federal Quality System Regulation 21CFR820. The successful candidate is experienced in using and maintaining a Quality System according to 21CFR820. It is expected that the QA/RA Specialist I will rapidly develop sufficient expertise to function independently. Maine Molecular is looking for the person with the energy and experience to step into this vital position in a growing company and grow along with us.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
A cover letter is required.
Contact Information:
Human Resources
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco, Maine 04072
LOCATION: MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We have a beautiful, state-of-the-art facility located in Saco, right next to the Eastern Trail. Come join us!
Job Type: Full-time
Benefits:
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Work Location: In person
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