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Lockheed Martin Chelmsford, United StatesJob ID: 661173BR Date posted: Feb. 15, 2024 Program: Functional Description:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members that are accountable ...
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Lockheed Martin Corporation Chelmsford, United StatesJob Description · Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members that are accountable for managing Supplier Quality Engineers, a supervised tea ...
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3 weeks ago
Lockheed Martin Corporation Chelmsford, United StatesJob DescriptionLockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members that are accountable for managing Supplier Quality Engineers, a supervised team of ...
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Functional Quality Assurance Manager
3 weeks ago
Lockheed Martin Chelmsford, United States· Description:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members that are accountable for managing Supplier Quality Engineers, a supervised team of ...
Quality Assurance Manager - Tyngsboro, United States - Talent the Right Solution
3 weeks ago
Description
Job DescriptionJob Description
Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services.
RESPONSIBILITIES:
Oversee the company's adherence to domestic and international regulatory standards, including FDA regulations, ISO standards, ASTM, and European Medical Device Regulation, for medical device design and development.
Lead the development, implementation, and maintenance of the Quality Management System (QMS) and quality procedures, aligning them with operational changes and reporting quality and regulatory issues to leadership.
Manage product conformity, including the evaluation of nonconforming products, and lead corrective actions for QMS audits, ensuring no repeat non-conformances from audits.
Provide strategic regulatory guidance, oversee risk management, validation, and conformity activities, and lead the transition to and management of an electronic QMS system.
Coordinate external audits, FDA Inspections, and conduct Management Reviews to ensure QMS effectiveness, serving as the company's main regulatory liaison for FDA correspondence, registrations, and device listings.
Offer regulatory advice and support to the company and its subsidiaries, ensuring staff compliance with regulatory affairs and quality management practices, and maintain up-to-date knowledge of regulatory requirements in the US, EU, and other regions.
Engage in global standards organizations' committee work, demonstrate proficiency in relevant technologies, and function within an FDA, CGMP, and ISO environment, with periodic travel primarily within the United States and other duties as assigned.
Qualifications:
Minimum of five years' experience in quality assurance management for manufactured products and processes
needs to have more physical product manufacturing and not just software quality experience
Previous experience with quality assurance of Medical Devices
Previous ISO 13485 experience required
Proficiency in conducting QMS audits within a regulated setting.
Skilled in drafting standard operating procedures, quality assurance protocols, work instructions, and documentation
Comprehensive understanding of legal and regulatory standards at all levels
BENEFITS :
Health Insurance (medical, dental, vision)
401K with match
PTO, Paid Holidays
Bonuses
ST & LT Disability
Pet-friendly
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