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Contact Name: DAVE

Job Details: Quality Director Date: Apr 08 2021

Job Reference: 2793
Job Category: IT Jobs [ View All IT Jobs Jobs ]
Company Type Recruiter
Employment type: Full Time, Contract
Degree: High School
Experience: 3 years
Location: Boston, Massachusetts, 02103
Job Skills: Bonus Eligible - Yes
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Job Description

• Maintain and improve the Company’s Quality System policies and procedures to ensure full compliance with all applicable domestic and international regulations/standards, specifically including those requirements for an FDA-regulated Company.
• Ensure effective corporate management review procedures and apply such procedures across all Company disciplines as may be necessary.
• Act as the Company’s key person in all regulatory and quality audits.
• Formulate and execute corrective action plans resulting from process inspections.
• Develop and manage the Company’s internal audit process including the planning and implementation of practice FDA audits and remediation activities.
• Manage supplier qualification
• Manage all of the Company’s U.S. and international regulatory activities, including maintaining appropriate regulatory certifications, preparing and submitting regulatory documents, and acting as the Company’s primary liaison with regulatory agencies.


• Bachelor's degree (at a minimum) in a technical or scientific field.
• 10 years’ experience in a Quality/Regulatory Compliance environment with at least 5 years of demonstrated and verifiable leadership in directing the activities of complex teams.
• Experience in Medical Device manufacturing is essential.
• Experienced with application of FDA and ISO quality standards in a government regulated industry.
• Direct experience with FDA and Notified Body inspections.
• Must be a Certified Lead Auditor, Internal/External Audits.
• Experience with initial regulatory submissions as well as periodic submission of updates.

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