- Do you have a minimum of five years' experience in quality
- Are you skilled in drafting standard operating procedures,
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Functional Quality Assurance Manager
1 week ago
Lockheed Martin Chelmsford, United States**Job 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 ...
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Quality Assurance Manager
2 weeks ago
San-tron, Inc. Ipswich, United StatesThe **Quality Assurance Manage**r is responsible for leading the development, implementation and execution of San-tron's global quality system with the goal of continuous improvement towards zero defects. This position reports to the Company President. · PRIMARY RESPONSIBILITIES: ...
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Quality Assurance Manager
3 weeks ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
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Quality Assurance Manager
2 weeks ago
Comprehensive Staffing Solutions of Georgia Tyngsboro, United StatesJob Description · The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services. Oversee the company's adherence to domestic and international regulatory standar ...
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Manager of Quality Assurance
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Hydro Recruiting Tyngsboro, United StatesJob Description · Job Description · J ob Title: Manager of Quality Assurance · Industry: Biotechnology · Functional Area: Quality Assurance · Minimum Requirements: · 5-8 Years of Quality Assurance Management Experience · Bachelors Degree · ISO 13485 experience required · Profic ...
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Quality Assurance Manager
1 week ago
KLM Careers Tyngsborough, United StatesQuality Assurance Manager - MA · Tyngsborough, MA · Must be a US Citizen or Green Card holder · The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services. · R ...
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Quality Assurance Manager
3 weeks ago
Comprehensive Staffing Solutions of Georgia Tyngsboro, United StatesJob DescriptionThe Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services.Oversee the company's adherence to domestic and international regulatory standards, i ...
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Quality Assurance Manager
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Talent the Right Solution Tyngsboro, United StatesJob Description · Job 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 ...
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Quality Assurance Manager
3 weeks ago
Talent the Right Solution Town of Tyngsborough, United StatesJob Description · Job DescriptionQuality 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 ...
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Quality Assurance Manager
1 week ago
KLM Careers Town of Tyngsborough, United StatesJob Description · Job DescriptionQuality Assurance Manager - MA · Tyngsborough, MA · Must be a US Citizen or Green Card holder · The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's produ ...
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Quality Assurance Manager
23 hours ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
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Quality Assurance Test Manager
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NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
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Quality Assurance Program Manager
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INTEGRA TESTING SERVICES Needham, United StatesThe Quality Manager is responsible for leading the Quality Program for all CE Services locations and managing the onsite Microbiology Laboratory. · The Quality Manager assumes overall responsibility in ensuring that the division maintains operational and quality systems in a stat ...
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Manager, Quality Assurance Operations
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ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
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Vertex Pharmaceuticals Boston, United StatesJob Description · General Position Summary: · The Audit and Inspection Management Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting i ...
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Emerald Enterprises Cambridge, MA, United States FreelanceAre you looking to take the next step in your career? At Brunel, you have the opportunity to continuously develop yourself with renowned clients across industries. Take the decisive step in your career today and apply with us as a Project Manager for Automotive Quality and Produc ...
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Functional Quality Assurance Manager
2 weeks ago
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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Functional Quality Assurance Manager
2 weeks ago
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 ...
-
Functional Quality Assurance Manager
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 ...
-
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 - KLM Careers
Description
Quality AssuranceManager -
MA
Tyngsborough,
MA
Must
be a
US Citizen or Green Card holder
The 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
Required Knowledge, Skills, and Abilities:
(Hiring Companies ATS
Questions) :
needs to have
more physical product manufacturing and not just software
quality experience.
2.
Do you have previous
experience with quality assurance of Medical Devices
3.
Do you have previous
ISO 13485 experience?
4.
Do you have proficiency
in conducting QMS audits within a regulated setting.
assurance protocols, work instructions, and documentation.
6.
Must be a US
Citizen or Green Card holder.
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