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Quality Assurance Engineer

2 months ago

Columbia, South Carolina, United States Gilero Full time

Job Overview:

The Quality Assurance Engineer is accountable for ensuring the highest standards of quality throughout the design, development, and manufacturing processes of medical devices and combination products. This role emphasizes risk management, appropriate design evaluations, ongoing enhancements, and the execution of qualification strategies.

Key Responsibilities:

  • Act as the quality representative in product development initiatives, providing essential support for both development and commercialization efforts. Create documentation for design history files during the product development lifecycle.
  • Convert user feedback into quantifiable product specifications and requirements.
  • Assist in design verification and validation processes, including the creation of testing protocols and documentation.
  • Ensure that project documentation is compliant, offering clear visibility and traceability in accordance with best practices and regulatory standards.
  • Oversee, analyze, and continuously enhance assigned quality system components (such as CAPA, Complaints, Supplier Management, and External Audits).
  • Engage in risk assessment activities related to medical devices.
  • Maintain comprehensive and accurate Design History Files, including necessary regulatory submission documents.
  • Support the transition to manufacturing by preparing and executing process validation protocols (IQ/OQ/PQ) and developing inspection plans for production.
  • Investigate and resolve issues related to nonconforming materials during various phases of product development and production.
  • Draft new or updated procedures, provide training to team members, and release quality system documentation as needed.
  • Facilitate both internal and external audits.
  • Assist in the selection, qualification, and ongoing evaluation of suppliers.
  • Lead investigations to identify root causes and failure modes.
  • Maintain quality documentation, summarize findings, and report quality metrics to the organization.
  • Manage the initiation, investigation, and resolution of quality events, including nonconformances, CAPA, change control, and complaints, while performing effectiveness checks.

Qualifications:

  • Minimum Requirements:
  1. Bachelor's degree in engineering, science, or a related field.
  2. 0-5 years of experience in a regulated manufacturing or development setting.
  3. Familiarity with FDA 820 CFRs/ISO 13485/cGMP quality management systems and requirements for medical device and combination product development and manufacturing.
  4. Experience with risk analysis and continuous improvement methodologies.
  5. Extensive knowledge of GxP requirements.
  6. Strong written and verbal communication skills.
  7. Experience in leading or supporting audits.
  • Preferred Qualifications:
  1. Master's or advanced degree in a relevant discipline.
  2. 5+ years of experience in pharmaceutical or medical device manufacturing or development.
  3. Exceptional interpersonal, change management, planning, and organizational skills.
  4. Outstanding oral, written, and presentation communication abilities.
  5. Knowledge of GxP terminology and experience in phase-appropriate environments from pre-clinical to commercial.
  6. Project management experience.
  7. CQE ASQ or similar certification.

Personal Attributes:

  • Exemplifies Gilero Core Values: Collaboration, Innovation, Excellence, Integrity.
  • Thrives in a dynamic, entrepreneurial environment.
  • Dedicated to delivering exceptional quality service to both internal and external stakeholders.
  • Complies with established policies and procedures while contributing to ongoing improvements.