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Quality Specialist

3 months ago

Waterloo Ontario ML, City of Toronto, Canada Intellectt Inc Full time

Job Title: Quality Specialist

Location: Philadelphia, PA

Duration: 12 months

We are happy to sponsor TN Visa for citizens with Canadian passport.

Job Description

The Quality Specialist ensures compliance with ISO 13485, MDSAP, EU MDR 2017/745, US FDA 21 CFR Part 820, and other regulatory requirements. This role supports Deep Health’s Quality Domain, enhancing customer satisfaction and team collaboration.

Education & Experience
  1. Education: B.E. in Mechanical or Biomedical Engineering.
  2. Experience: 6-8 years in Medical Devices Quality (SaMD experience preferred).
Role And Responsibilities
  1. Ensure compliance with ISO 13485, MDSAP, EU MDR 2017/745, US FDA 21 CFR Part 820.
  2. Support QMS integration across sites.
  3. Maintain quality procedures and work instructions for CAPA, complaints, supplier quality, training, internal audit, risk, and design remediation.
  4. Assist with design remediation, including DHF, risk files, and cybersecurity.
  5. Support ongoing design projects and LMS implementation.
  6. Validate data and document migration.
  7. Resolve technical queries promptly.
  8. Engage with clients and cross-functional teams.
  9. Deliver customized solutions to meet client needs.
  10. Ensure process compliance and meet delivery schedules.
Skills
  1. Quality Management System (QMS): Hands-on experience with Quality Specialist roles in SaMD/Software Products.
  2. Cybersecurity: Implementation of cybersecurity guidelines.
  3. Technical Skills: Proficient in Microsoft Office (Excel, PowerPoint, Outlook, Teams).
  4. Problem-Solving: High learning agility and quick issue resolution.
  5. Customer Orientation: Able to meet customer demands and tight deadlines.
  6. Self-Motivation: Proactive, organized, and team-oriented.
  7. Communication: Strong verbal and written skills in English.
  8. Interpersonal Skills: Effective communication with diverse stakeholders, mainly virtually.
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