Quality Assurance

3 weeks ago

Westborough, United States Abacus Full time
Job Description:
The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Key responsibilities include:
  • Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools.
  • Provides development and implementation support for process verification and validation plans, equipment qualification documents and Validation Plans (Product or Process specific plans).
  • Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, action plans, and for corrective and preventive actions (CAPA Program).
  • Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Failure Mode Analysis, etc.
  • Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
  • Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
  • Reviews and approves manufacturing process change requests. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Qualifications:
  • Bachelor's degree
  • 5 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
  • Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
  • Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies,
  • Demonstrated experience using word processing, spreadsheet, and presentation software.
  • Demonstrated understanding of continuous quality / process improvement tools.

Schedule
Mon-Fri 8-5 100%

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