Quality Assurance Specialist

3 weeks ago

Montreal, Quebec, Canada Boston Scientific Full time

About the Role:

The Design Quality I individual provides quality engineering support to new product development projects and sustaining projects for current products on the market. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your Responsibilities Will Include:

  • Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
  • Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
  • Provide quality and compliance input for post market product sustaining activities, such as design changes, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions.
  • Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Builts quality into all aspects of work by maintaining compliance to all quality requirements.
  • Support internal and external regulatory audits as required.
  • Other duties as necessary or required by the organization.

Required Qualifications:

  • Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent.
  • 0-2 years of related work experience.
  • Medical device experience.
  • Competent with use of Microsoft Office Suite.

Preferred Qualifications:

  • Focus on detailed work with emphasis on accuracy and completeness.
  • Excellent organizational and planning skills; drives for results.
  • Strong communication (oral and written) and presentation skills.
  • High energy problem solver capable of driving items to closure.
  • Ability to collaborate and work on a global team.

Requisition ID: 588148

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

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