Current jobs related to Quality Assurance Manager - Town of Tyngsborough - KLM Careers

  • Quality Assurance Manager

    2 weeks ago

    King of Prussia, Pennsylvania, United States Camber Spine Full time

    Job Title: Quality Assurance ManagerCamber Spine is seeking a highly skilled Quality Assurance Manager to lead the quality and regulatory department. The successful candidate will be responsible for planning, coordinating, and managing quality assurance activities associated with all quality management system requirements.Key Responsibilities:Manage the...

  • Quality Assurance Manager

    7 days ago

    king of prussia, United States Camber Spine Full time

    The Quality Assurance Manager leads the quality and regulatory department for Camber Spine. Specifically, this role will plan, coordinate, and manage the quality assurance (QA) activities associated with all quality management system (QMS) requirements per ISO 13485 and 21 CFR 820. This individual will manage the department and be part of the daily QMS...

  • Quality Assurance Manager

    1 month ago

    King of Prussia, United States Camber Spine Full time

    The Quality Assurance Manager leads the quality and regulatory department for Camber Spine. Specifically, this role will plan, coordinate, and manage the quality assurance (QA) activities associated with all quality management system (QMS) requirements per ISO 13485 and 21 CFR 820. This individual will manage the department and be part of the daily QMS...

  • Quality Assurance Manager

    1 week ago

    King of Prussia, Pennsylvania, United States Vibrantz Technologies Inc. Full time

    Quality Manager Job DescriptionVibrantz Technologies Inc. is seeking a highly skilled Quality Manager to join our team in King of Prussia, PA. As a Quality Manager, you will be responsible for developing, managing, and implementing the site's quality management system.Key Responsibilities:Evaluate processes, procedures, and applications that contribute to...

  • Global Quality Assurance Manager

    2 weeks ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    About the RoleCSL Behring is seeking a highly skilled Global Quality Assurance Manager to join our team. As a key member of our Global Quality Assurance team, you will be responsible for managing global quality assurance activities in various regions and globally.Key Responsibilities:Develop and implement global quality audit programs for assigned projects...

  • Quality Assurance System Manager

    1 month ago

    Township of Bernards, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is committed to the development and provision of groundbreaking pharmaceutical solutions aimed at enhancing healthcare standards and addressing diverse, unmet medical needs worldwide through our exceptional scientific expertise and technology. With over a century of scientific knowledge...

  • Director, Quality Assurance

    1 week ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job Title: Director, Quality AssuranceCSL Behring is seeking a highly skilled Director, Quality Assurance to lead the development and implementation of quality assurance strategies for our US Commercial Marketing team.The ideal candidate will have a strong background in quality assurance, with experience in developing and implementing quality systems,...

  • Director, Quality Assurance

    5 days ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job Title: Director, Quality AssuranceCSL Behring is seeking a highly skilled Director, Quality Assurance to lead our quality assurance efforts and ensure the highest standards of quality in our products.The successful candidate will have a strong background in quality assurance, with experience in leading cross-functional teams and implementing quality...

  • Lead GCP Quality Assurance Manager

    1 month ago

    King of Prussia, Pennsylvania, United States EXELIXIS Full time

    JOB SUMMARY:Accountable for enhancing, implementing, and maintaining quality assurance systems and operations that support Good Clinical Practice (GCP) and Pharmacovigilance (PV) activities. Provides assistance in the planning and execution of vendor audits and related documentation tasks.Key Responsibilities:Assist in the formulation of internal processes...

  • Lead GCP Quality Assurance Manager

    1 month ago

    King of Prussia, Pennsylvania, United States EXELIXIS Full time

    JOB DESCRIPTIONJOB PURPOSE:Accountable for enhancing, implementing, and maintaining quality assurance systems and operations that support Good Clinical Practice (GCP) and Pharmacovigilance (PV) activities. Provides assistance in the planning and execution of vendor audits and related documentation tasks.Essential Duties And Responsibilities:Assist in the...

  • Quality Assurance Executive

    1 month ago

    King of Prussia, Pennsylvania, United States PetroChoice Full time

    OverviewSUMMARY: The Quality Assurance Executive at PetroChoice is responsible for overseeing, organizing, and leading the quality assurance teams across our manufacturing and distribution operations. This role entails conducting comprehensive quality assurance and control across all facilities and related entities. The Quality Assurance Executive will...

  • VP, Quality Assurance

    1 week ago

    king of prussia, United States Franklin Biolabs Full time

    Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive...

  • VP, Quality Assurance

    2 weeks ago

    King of Prussia, United States Franklin Biolabs Full time

    Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive...

  • Director, Quality Assurance

    7 days ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job Title: Director, QualityCSL Behring is seeking a highly skilled and experienced Director, Quality to lead our Quality Assurance team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our products and processes.Key Responsibilities:Develop and implement quality strategies to ensure compliance...

  • Director, Quality Assurance

    6 days ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job Title: Director, Quality AssuranceCSL Behring is seeking a highly skilled Director, Quality Assurance to lead the development and implementation of quality assurance strategies for our rare disease portfolio.The ideal candidate will have a strong background in quality assurance, with experience in developing and implementing quality systems, conducting...

  • Quality Assurance Coordinator

    2 weeks ago

    King of Prussia, Pennsylvania, United States PSI CRO Full time

    Job DescriptionAs a Quality Assurance Assistant at PSI CRO, you will play a crucial role in ensuring the highest standards of quality in our operations. Your primary responsibilities will include:Key ResponsibilitiesQuality Assurance Study Audits: Assist in scheduling and preparing quality assurance study audits, ensuring timely and efficient...

  • Quality Assurance Specialist

    3 weeks ago

    King of Prussia, Pennsylvania, United States Exelixis Full time

    Job Summary:Exelixis is seeking a highly skilled Senior Quality Assurance Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for assisting in the development, implementation, and maintenance of quality systems and activities supporting Good Clinical Practice (GCP) and Pharmacovigilance (PV) operations.Key...

  • Quality Assurance Leader

    1 month ago

    King of Prussia, Pennsylvania, United States MAU Full time

    Job OverviewMAU is seeking a Quality Assurance Leader for a prominent client. In this role, you will be responsible for the development, management, and execution of the quality management framework at the site. This involves assessing processes, protocols, and applications that align with the site’s goals while maintaining a robust quality program. Your...

  • Quality Assurance Leader

    1 month ago

    King of Prussia, Pennsylvania, United States Vibrantz Technologies Inc. Full time

    Vibrantz Technologies Inc. is seeking a Quality Assurance Leader. In this role, you will be responsible for the development, management, and execution of the quality management framework at the site. This encompasses the assessment of processes, protocols, and applications that align with site goals while ensuring a robust quality program is in place. Your...

  • VP, Quality Assurance Director

    2 days ago

    King of Prussia, Pennsylvania, United States Franklin Biolabs Full time

    Job Title: VP, Quality AssuranceFranklin Biolabs is seeking a highly experienced and skilled VP, Quality Assurance to join our team. As a key member of our leadership team, you will be responsible for developing and implementing quality assurance strategies, policies, and procedures to maintain the highest level of product and service excellence.Key...

Quality Assurance Manager

4 months ago

Town of Tyngsborough, United States KLM Careers Full time
Job DescriptionJob Description

Quality 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.

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):

1. Do you have a 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.

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.

5. Are you skilled in drafting standard operating procedures, quality assurance protocols, work instructions, and documentation.

6. Must be a US Citizen or Green Card holder.