Overview
Director of Quality Assurance Jobs in Hopedale, Massachusetts, USA at BioTalent
Location: Hopedale
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RA/QA Medtech & Life Sciences Recruitment for New England
Overview:
A leading organization is seeking an experienced Quality Assurance leader to oversee and drive quality strategy across multiple sites in the Americas. This role ensures compliance with regulatory standards (ISO 9001, ISO 13485, 21 CFR 820, etc.), and fosters a strong culture of quality and operational excellence.
Key Responsibilities:
Lead the Americas Quality Assurance function, aligning quality initiatives with overall business strategy and objectives.
Develop and implement a comprehensive Quality Management System (QMS) across multiple sites, ensuring compliance with industry regulations and standards.
Collaborate with cross-functional teams and key stakeholders to drive continuous improvement in product quality, operational processes, and customer satisfaction.
Oversee multi-site QA teams, ensuring they are well-structured, highly skilled, and aligned with corporate goals.
Support business development activities, including due diligence for M&A targets and integration of newly acquired companies into the QMS.
Lead major quality initiatives, risk-based assessments, and harmonization of quality processes across locations.
Act as a key representative for regulatory audits and compliance-related activities.
Qualifications:
10+ years of experience in Quality Leadership roles.
Strong expertise in quality systems compliance, including ISO 9001, ISO 13485, and 21 CFR 820.
Proven track record in leading multi-site QA teams and driving strategic quality improvements.
This position offers a significant leadership opportunity with direct responsibility for QA teams across multiple U.S. locations. The ideal candidate will be a strategic thinker with a passion for quality and continuous improvement.
Seniority level
Seniority level Director
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries Medical Equipment Manufacturing and Appliances, Electrical, and Electronics Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Student loan assistance
Tuition assistance
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Title: Director of Quality Assurance
Company: BioTalent
Location: Hopedale, Massachusetts, USA
Category: Quality Assurance – QA/QC
