Quality Engineer

4 weeks ago

St Michael, United States Talencio Full time

COMPANY OVERVIEW:

Our client is a leading innovator in the medical device sector, specializing in unique solutions for bariatric, metabolic, and digestive surgery. With its revolutionary incision-less anastomosis technology employing magnets, the company is redefining medical innovation boundaries. It was established by a highly successful medical device CEO and a distinguished bariatric surgeon and is presently engaged in groundbreaking clinical trials OUS.


Are you a Quality Engineer with a passion for groundbreaking solutions and a desire to be part of charting new territory? If so, we’d love to connect.


Position Overview:

At the forefront of innovation, the Quality Engineer role is your gateway to shaping the future of healthcare technology. Join our client’s dynamic team as they revolutionize the industry, ensuring the highest standards of quality and compliance are met every step of the way. Collaborating closely with cross-functional teams, you'll play a pivotal role in maintaining and enhancing our client’s established Quality System.



Primary Responsibilities

  • Compliance and Standards Adherence: Assist in ensuring the company's strict adherence to established Quality System protocols and relevant regulations and standards, fostering a culture of excellence and compliance throughout the organization.
  • Cross-Functional Collaboration: Collaborate closely with Research and Development (R&D) and Manufacturing teams, championing compliance with design and production controls.
  • Test Method Development: Collaborate with R&D to devise comprehensive test methods for products, rooted in performance specifications and rigorous risk analysis, ensuring the highest standards of quality and reliability.
  • Documentation and Reporting: Develop and document test plans, protocols, specifications, procedures, and reports, providing a clear roadmap for quality assurance processes and ensuring thorough documentation of results.
  • Testing and Validation: Execute tests according to varied protocol requirements, leveraging your technical expertise to validate product performance and reliability, driving continuous improvement.
  • Process Development: Development and implement processes for product development and manufacturing, optimizing efficiency and ensuring consistency in quality standards.
  • Root Cause Analysis: Conduct in-depth technical and statistical investigations into quality issues, including the disposition of nonconforming material. Identify primary root causes and spearhead the implementation of corrective and preventive actions, driving continuous improvement.
  • Risk Analysis Support: Assist in the completion of risk analyses, including Failure Mode Effects and Criticality Analysis (FMECA), providing valuable insights that inform strategic decision-making and risk mitigation efforts.
  • Supplier Quality Management: Contribute to defining supplier quality specifications, sampling plans, and vendor qualification processes, ensuring the integrity of the supply chain and adherence to quality standards.
  • Documentation Review and Audit: Perform quality engineering reviews of design and manufacturing documentation, ensuring compliance with stated requirements. Additionally, conduct audits of manufacturing operations to assure adherence to written procedures, maintaining the highest standards of quality and consistency.
  • Product Inspection and Release: Assist with receiving inspection of product components, including setup of measurement systems for new components. Additionally, support final product inspection and release processes, ensuring adherence to quality standards.
  • Equipment Maintenance: Assist with calibration and preventive maintenance activities for equipment as needed, ensuring the reliability and accuracy of measurement and testing instruments.
  • Communication and Presentation: Prepare and present technical and program information to team members and management, effectively communicating findings and recommendations to drive informed decision-making and strategic planning.
  • Adaptability and Flexibility: Perform other duties and responsibilities as assigned, demonstrating adaptability and versatility in addressing evolving organizational needs and priorities.



Requirements, Qualifications, Education & Experience

  • B.S. degree in engineering or related field (e.g. mechanical, manufacturing, industrial, biomedical).
  • Two years of experience in the medical device industry preferred.
  • Proficiency in SolidWorks or other CAD software.
  • Strong verbal and written communication skills with the ability to communicate ideas to all levels of the organization.
  • Ability to work in office, lab, and production floor environments.

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