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Job Summary |
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Director of Quality Assurance - Medical Device
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POSTED: Oct 30
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| Salary: |
Open |
Location: |
East - Central New Jersey |
| Employer: |
Confidential |
Type: |
Full Time - Experienced |
| Categories: |
Government, Regulatory and Code, Quality |
Required Education: |
4 Year Degree
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Job Description |
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The Client is a medical device company located in East-Central New Jersey. They are seeking a Director of Quality Assurance to provide leadership for the development, implementation, communication and maintenance of quality systems. This includes US FDA regulations for medical devices, ISO 13485: 2003 and the Canadian Medical Devices Regulations and European Community Medical Device Directives. Local candidates preferred. No paid relocation.
Responsibilities
• Generate, implement and maintain internal quality procedures and systems to comply with applicable regulatory requirements • Ensure an effective Corrective Action and Preventive Action Program • Ensure an effective Internal Audit Program • Ensure an effective vendor qualification program • Support External Regulatory Audits • Ensure effective document control and change control processes • Ensure customer complaint records and files are maintained, with closure of files • Ensure Mandatory Problem Reporting to Health Canada, Europe (MDD) and MDR reporting to the FDA. • Ensure continued quality improvement processes are generated and maintained • Understand conformance and product requirements and assist in communicating to company employees • Support a Management Review process to monitor and evaluate the Quality systems effectiveness • Report on the status of the quality system to VP of RA/QA • Establish a company wide training program that complies with cGMP requirements and ISO 13485:2003 • Support business and manufacturing initiatives in order to increase manufacturing capacity, diversify product base and diversify customer base while meeting quality requirements • Lead interactions with regulatory authorities related to quality and compliance policies, guidelines, and systems • Develop, implement, and lead Quality Assurance functions of the company • Assure internal and external compliance with regulatory requirements for G(X)P (GLP, GCP, GMP) activities • Support inputs to VP of RA/QA for departmental budgets in accordance to business strategy and production plans • Supports the needs of Product Development
| NOTES: |
Local Residents Preferred (No Relo).
Additional Salary Information: Salary plus bonus and benefit package
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Requirements |
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Requirements • BA/BS in Engineering or Life Sciences (advanced degree preferred) with minimum of 5 years experience managing Quality Assurance & Regulatory Compliance Systems in the biotechnology, pharmaceutical or medical devices industry. • Experience interacting with regulatory authorities with successful preparation of 510K filing or CE mark filing. • Experience in ISO, QSR and QSIT-type audits. • Solid understanding of cGMPs, GLPs, GCPs, ICH, and FDA guidelines, experience working with the FDA, and knowledge and experience with non-U.S. regulatory authorities.
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