Product Development Quality Assurance Specialist

4 days ago


Montreal, Quebec, Canada Boston Scientific Full time
About the Role:

The Design Assurance Quality Engineer III plays a vital role in ensuring the quality and compliance of new product development projects and sustaining projects for current products on the market. They develop, establish, and maintain quality-engineering methodologies, systems, and practices that meet regulatory requirements.

Your Responsibilities Will Include:
  • Providing quality and compliance input to project teams for project decisions and deliverables, including design change analysis, design inputs, design outputs, test methods, design reviews, design verification and validation, usability testing, software validation, process validation, and labeling.
  • Supporting software verification and validation activities for new products.
  • Performing risk evaluation and associated management activities related to product development, including product risk analysis and mitigation of software issues to ensure compliance with ISO 14971 and demonstrating a primary commitment to patient safety.
  • Supporting product cybersecurity assessments in conjunction with a cross-functional team.
  • Providing quality and compliance input for post-market product sustaining activities, such as design changes, NCEPs, CAPAs, PIRs, field signals evaluations, and field actions.
  • Applying technical skills, including sound, systematic problem-solving methodologies, in identifying, prioritizing, communicating, and resolving quality issues.
  • Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Capable of working independently on highly specialized projects with long-range objectives.
  • Building quality into all aspects of work by maintaining compliance to all quality requirements.
  • Supporting internal and external regulatory audits as required.
Required Qualifications:
  • Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related field.
  • Minimum of 6 years of medical device engineering experience.
  • In-depth familiarity with FDA, ISO, MDD, EU MDR, and medical device industry quality requirements associated with product development, design controls, and product risk management.
  • Strong communication and presentation skills.
  • Solid technical writing skills.
Estimated Salary: $120,000 - $150,000 per year

  • Montreal, Quebec, Canada Dehumidified Air Solutions Full time

    Quality Assurance SpecialistAt Dehumidified Air Solutions, we are seeking a Quality Assurance Specialist to join our Quality Assurance Team. The main task of this team is to ensure that the quality of our DAS products meets our internal quality standards.The Quality Assurance Specialist will be responsible for creating Work Instructions, describing how to...


  • Montreal, Quebec, Canada Dehumidified Air Solutions Full time

    Quality Assurance SpecialistAt Dehumidified Air Solutions, we are seeking a Quality Assurance Specialist to join our Quality Assurance Team. The main task of this team is to ensure that the quality of our DAS products meets our internal quality standards.The Quality Assurance Specialist will be responsible for:Creating Work Instructions to describe how to...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job DescriptionWe are seeking a Quality Assurance Specialist to join our team at MTLs Aerostructure. As a Quality Assurance Specialist, you will be responsible for developing and conducting production, inventory, and quality assurance programs. You will also conduct work measurement or other studies, collect and compile operational or experimental data, and...


  • Montreal, Quebec, Canada Electronic Arts Full time

    We are seeking a Quality Assurance Specialist to join our team at Electronic Arts. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality of our games by working closely with our development teams to identify and resolve issues.Key Responsibilities:Collaborate with development teams to identify and resolve quality...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at mtlS Aerostructure. As a Quality Assurance Specialist, you will be responsible for developing and conducting production, inventory, and quality assurance programs.Key Responsibilities:Develop and conduct production,...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a Quality Assurance Specialist to join our team at MTLs Aerostructure. As a Quality Assurance Specialist, you will be responsible for developing and conducting production, inventory, and quality assurance programs. You will also conduct work measurement or other studies, collect and compile...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at mtlS Aerostructure. As a Quality Assurance Specialist, you will be responsible for developing and conducting production, inventory, and quality assurance programs.Key Responsibilities:Develop and conduct production,...


  • Montreal, Quebec, Canada Dehumidified Air Solutions Full time

    Quality Assurance SpecialistAt Dehumidified Air Solutions, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products meets our internal standards.Main Responsibilities:Conduct production inspections at designated production stations...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    We are seeking a highly skilled Quality Assurance Specialist to join our team at mtlS aerostructure. As a key member of our quality team, you will be responsible for developing and implementing production, inventory, and quality assurance programs that meet the highest standards of quality and safety.Key responsibilities include:Developing and conducting...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at mtlS Aerostructure. As a Quality Assurance Specialist, you will be responsible for developing and conducting production, inventory, and quality assurance programs. You will also conduct work measurement or other studies,...


  • Montreal, Quebec, Canada Dehumidified Air Solutions Full time

    At Dehumidified Air Solutions, we are seeking a Quality Assurance Specialist to join our Quality Assurance Team. The main goal of this role is to ensure that the quality of our DAS products meets our internal quality standards.The Quality Assurance Specialist will be responsible for creating Work Instructions, educating employees on these instructions, and...


  • Montreal, Quebec, Canada St-Amour & Associates, Senc. Full time

    Job Opportunity: We are seeking a highly skilled Quality Assurance Specialist to join our team at St-Amour & Associates, Senc. in the pharmaceutical industry.About the Role: As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes. You will work closely with our team to identify and implement quality...


  • Montreal, Quebec, Canada St-Amour & Associates, Senc. Full time

    Job Title: Quality Assurance SpecialistJob Description:We are seeking a highly skilled Quality Assurance Specialist to join our team at St-Amour & Associates, Senc. The ideal candidate will have a strong background in good manufacturing practices and experience in QA.Key Responsibilities:Ensure compliance with GMP regulationsConduct quality control...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    We are seeking a Quality Assurance Specialist to join our team at MTLS Aerostructure. In this role, you will be responsible for developing and conducting production, inventory, and quality assurance programs that meet the highest standards of quality and safety.Key responsibilities include:Program Development: Design, implement, and maintain quality...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    About MTL AerostructureWe are a dynamic company seeking a skilled Quality Assurance Technologist to join our team. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our products and services.Job SummaryThis is a permanent position offering a competitive salary range of $65,000 - $85,000 per year, depending on...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job DescriptionWe are seeking a Quality Assurance Specialist to join our team at MTLs Aerostructure. The successful candidate will be responsible for developing and conducting production, inventory, and quality assurance programs.Key ResponsibilitiesDevelop and implement quality assurance programs to ensure compliance with regulatory requirements and company...


  • Montreal, Quebec, Canada Electronic Arts Full time

    We are seeking a Quality Assurance Specialist to join our team at Electronic Arts. This role will be responsible for ensuring the highest quality of our games, working closely with developers, artists, and other stakeholders to identify and resolve issues.Key Responsibilities:Collaborate with cross-functional teams to develop and implement quality assurance...


  • Montreal, Quebec, Canada mtls aerostructure Full time

    Job DescriptionWe are seeking a Quality Assurance Specialist to join our team at MTLs Aerostructure. The successful candidate will be responsible for developing and conducting production, inventory, and quality assurance programs. This includes conducting work measurement or other studies, collecting and compiling operational or experimental data, and...


  • Montreal, Quebec, Canada Electronic Arts Full time

    We are seeking a Quality Assurance Specialist to join our team at Electronic Arts. This role will be responsible for ensuring the highest quality of our games by working closely with developers, artists, and other stakeholders.Key Responsibilities:Establish and maintain quality assurance processes for art, content production, and integration.Collaborate with...


  • Montreal, Quebec, Canada Randstad Canada Full time

    Job SummaryRandstad Canada is seeking an experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for managing non-conformances, risk management, product and process qualifications, and root cause investigation processes. You will also have the opportunity to work with a world-class organization...