Lead Quality Assurance Engineer

1 week ago


Bedford, Massachusetts, United States InfraredX, Inc. Full time
Lead Quality Assurance Engineer

As a Lead Quality Assurance Engineer at InfraredX, you will play a crucial role in ensuring the excellence of our product designs, sourcing, and manufacturing processes. Your expertise will guide the development teams during the transition of intricate electromechanical medical devices from concept to production. You will be responsible for formulating, reviewing, and executing engineering modifications while establishing quality inspection standards.

Key Responsibilities:

  • Design and validate testing methodologies and inspection protocols. Collaborate in the creation of testing documentation and reports as necessary.
  • Implement and assess engineering change requests.
  • Establish product acceptance criteria and analyze process capabilities.
  • Engage in product risk assessments and FMEA evaluations.
  • Identify, prioritize, communicate, and resolve quality challenges in a fast-paced and evolving business landscape.
  • Assist in the oversight and certification of controlled environments.
  • Develop and apply effective process controls to facilitate the design, qualification, and production of products.
  • Generate and analyze quality metrics to identify trends impacting product quality. Conduct failure analyses and drive corrective actions to address recurring issues through the CAPA process.
  • Contribute to the development of inspection criteria for products, work-in-progress, and sourced components.
  • Participate in NMR/MRB activities, including material evaluations.
  • Engage in internal and external audits and contribute to quality system enhancement activities to ensure compliance with various regulatory standards.
  • Support the complaint management process as needed.
  • Assist in design control initiatives as required.

Requirements:

  • Bachelor's degree in a technical field, preferably in Electrical or Mechanical Engineering.
  • 5 to 7 years of experience in the medical device sector.
  • Excellent written and verbal communication skills, with a proven track record in utilizing quality tools and methodologies.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Familiarity with 21 CFR 820, MDD/MDR, ISO 13485, ISO 14971, design verification, process validation, product design control, CAPA, FMEA, and Kaizen methodologies.
  • Ability to work independently and collaboratively within a cross-functional team, manage multiple tasks, and meet stringent deadlines.
  • ISO 19011 certification is a plus.
  • Current ASQ certification is advantageous.
  • Ability to interact effectively with all organizational levels.


PIb286be893cbe



  • Bedford, Massachusetts, United States Actalent Full time

    Job DescriptionJob Summary: We are seeking a highly skilled Quality Assurance Specialist to lead the development and execution of comprehensive hardware quality assurance plans.Key Responsibilities:Design, implement, and oversee testing protocols for hardware components and systems.Conduct root cause analysis and drive corrective actions to address quality...


  • Bedford, Massachusetts, United States Entegris Full time

    Job Title: Quality Assurance Engineer Co-OpJob Description:At Entegris, we are committed to providing equal opportunity to all employees and applicants. Our policy is to recruit, hire, train, and reward employees for their individual abilities, achievements, and experience without regard to race, color, religion, sexual orientation, age, national origin,...


  • New Bedford, Massachusetts, United States Infraredx, a Nipro Company Full time

    As a key member of the engineering team at Infraredx, a Nipro Company, you will play a crucial role in ensuring the excellence of product design, sourcing, and manufacturing processes. Your expertise will be vital in guiding the transition of intricate electromechanical medical devices from development to production. You will be responsible for formulating,...


  • Bedford, Massachusetts, United States Anika Full time

    Job Overview:Anika Therapeutics is in search of a Validation Operations Manager to lead the validation initiatives at the Bedford Site. This position is crucial for managing the start-up, commissioning, qualification, and revalidation efforts for diverse manufacturing processes in alignment with contemporary industry standards. The Validation Operations...


  • New Bedford, Massachusetts, United States InfraredX, Inc. Full time

    Position Overview: The Lead Quality Assurance Inspector is tasked with overseeing inspection processes, executing tests and measurements, and gathering data to ensure compliance with quality standards. This role requires adherence to established protocols within the Quality Management System. The Lead Inspector will be responsible for generating and...


  • New Bedford, Massachusetts, United States CaptiveAire Systems Full time

    Job Description:CaptiveAire Systems is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for maintaining total quality for all products and processes within our manufacturing facility.Key Responsibilities:Lead the implementation and maintenance of various platforms and initiatives...


  • Bedford, Massachusetts, United States Actalent Full time

    Exciting Career OpportunityJoin a leading organization in the biotechnology sector as a Quality Assurance Chemist. This role is essential for ensuring the integrity and quality of products through rigorous testing and analysis.Key Responsibilities:• Conduct thorough testing of incoming raw materials in accordance with industry standards such as USP, EP, or...


  • New Bedford, Massachusetts, United States Taylor Hopkinson | Powered by Brunel Full time

    Position Overview:We are seeking a dedicated Quality Inspector to support a leading Offshore Windfarm Developer in the Northeast region.Key Responsibilities:Ensure adherence to quality standards through thorough inspections, management of incoming materials, and quality assessments on-site. Engage in initiatives aimed at enhancing quality and documenting...


  • New Bedford, Massachusetts, United States Taylor Hopkinson | Powered by Brunel Full time

    Position Overview:We are seeking a dedicated Quality Inspector to join a leading Offshore Windfarm Developer in the Northeast. This role is pivotal in maintaining the highest quality standards throughout our operations.Key Responsibilities:Conduct thorough inspections to ensure adherence to quality specifications and standards.Collaborate closely with the...


  • New Bedford, Massachusetts, United States Taylor Hopkinson | Powered by Brunel Full time

    Position Overview:We are seeking a dedicated Quality Inspector to support a leading Offshore Windfarm Developer in the Northeast region.Key Responsibilities:Ensure adherence to quality standards through comprehensive inspections, incoming materials oversight, and quality assessments. Engage in continuous improvement initiatives and contribute to the...


  • Bedford, Massachusetts, United States Actalent Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of our products.Key ResponsibilitiesDevelop and execute comprehensive quality assurance plans to ensure the quality and reliability of our...


  • New Bedford, Massachusetts, United States Technical Research & Manufacturing Inc Full time

    Job OverviewCompany Background:Technical Research & Manufacturing Inc. is a leader in the development and production of RF/Microwave components and integrated systems. We have been dedicated to delivering innovative solutions and a comprehensive range of standard products to our esteemed defense and aerospace clients since our inception.Our Work...


  • New Bedford, Massachusetts, United States Taylor Hopkinson | Powered by Brunel Full time

    Position Overview:We are seeking a dedicated Quality Inspector to support a prominent Offshore Windfarm Developer in the Northeast region.Key Responsibilities:Ensure adherence to quality standards through thorough inspections, incoming materials assessment, and quality evaluations. Engage in continuous improvement initiatives and contribute to internal...


  • Bedford, Massachusetts, United States Management Recruiters Inc. – The Boston Group Full time

    COMPANY OVERVIEW:Management Recruiters Inc. – The Boston Group specializes in the Medical Equipment Manufacturing sector, providing services to healthcare and medical device companies globally. They collaborate with clients from initial concept through to commercialization and operate multiple facilities across New England and Latin America.POSITION...


  • New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Position OverviewLantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a dedicated professional to oversee our GCP Clinical Quality Assurance (CQA) initiatives. With a legacy of over 60 years, Lantheus has been at the forefront of advancing medical imaging technology, enhancing patient care through a diverse range of products.Role...


  • New Bedford, Massachusetts, United States Kennedy-Donovan Center Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at the Kennedy-Donovan Center. As a Quality Assurance Specialist, you will play a critical role in ensuring that our programs and services meet the highest standards of quality and compliance.Key ResponsibilitiesAssist the Director of Quality and Compliance in ensuring...


  • Bedford, Massachusetts, United States InfraReDx Full time

    Key Responsibilities• Facilitate the complaint management process within the organization, ensuring adherence to Infraredx Quality Management Systems (QMS) related to Customer Complaints. Additional duties encompass supporting various QMS functions such as Management Review, Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NMRs), and Risk...


  • Bedford, Massachusetts, United States LogixHealth Full time

    Location: Hybrid position available.Signing Bonus: $400Position Overview:As a Medical Records Quality Assurance Specialist at LogixHealth, you will collaborate with various internal teams to enhance operational efficiency. Your role will be pivotal in processing medical records that have been evaluated by Coders and deemed un-codeable, contributing to our...


  • Bedford, Massachusetts, United States Entegris Full time

    Job Title: Quality Assurance Engineer Co-OpJob Description:We are seeking a Quality Assurance Engineer Co-Op to join our team at Entegris. As a Quality Assurance Engineer Co-Op, you will be responsible for ensuring the quality of our products and processes.The Role:This is a 6-month co-op assignment that will provide you with hands-on experience in quality...


  • Bedford, Massachusetts, United States Lantheus Full time

    Lantheus, a leader in the medical imaging sector, has been at the forefront of enhancing patient care for over six decades. Our innovative approach encompasses a wide array of diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions, all aimed at empowering healthcare professionals in their fight against disease. As a dynamic and...