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Company: ACRO STAFF
Contact Name: DAVE
Website: http://acrostaff.com

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.

Requirements

• 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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