Software/Electrical Quality & Regulatory Engineer (Med Device)

EG-GILERO - Morrisville, NC (30+ days ago)


EG-GILERO (www.eg-gilero.com) is growing and we seek talented engineers. We are a design and manufacturing company focused on medical and drug delivery devices. If you are a quality-minded engineer with expertise in software validation and regulatory submissions and you would like to join our product development team, we encourage you to apply. Thank you!

Job Purpose:

Responsible for developing, executing and improving company quality policies relating to the design, development, and production of new electromechanical medical devices.

Duties:

  • Oversee the development and implementation of quality system documentation for medical devices consisting of software and hardware
  • Participate as team member on new product development projects as quality function representative. Provide support for product and process development activities. Author design history file documents, as necessary, during the development process.
  • Prepare documentation for IEC 60601-1 compliance
  • Plan and oversee documentation for software verification and validation
  • Assist with software documentation and planning, in accordance with IEC-62304
  • Translate user input into measurable product requirements and specifications.
  • Develop and validate test methods to be used during design verification testing.
  • Support design verification and validation activities, including authoring test protocols and reports
  • Participate in risk analysis of new medical devices.
  • Assist in compiling and maintaining accurate and complete Design History Files, including regulatory submission documents.
  • Assist with manufacturing transfer, including preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
  • Investigate, disposition, and resolve nonconforming material events during product development, pre-production and production phases.
  • Lead internal corrective and preventative actions (CAPA) process and perform effectiveness checks as appropriate. Implement CAPA to address product or quality system related issues as assigned.
  • Author new or revise procedures, train team members and release quality system procedures, as required.
  • Support internal and external audits, as needed.
  • Support supplier selection, qualification and on-going monitoring.
  • Evaluate customer complaints. Facilitate failure investigations to determine root cause and failure modes. Document results to support company complaint handling system.
  • Maintain quality records, summarize data and report quality metrics to the organization.
  • Perform other quality or new product development-related duties, as required.

Skills/Qualifications:

  • Bachelor's Degree in Engineering or equivalent.
  • Minimum of 3-5 years of engineering or quality assurance experience (regulated environment preferred).
  • Working knowledge of and 21 CFR 820 Quality System Regulation (QSR) and ISO 13485:2003.
  • Considerable experience with IEC 60601-1, familiarity with IEC 62304
  • Experience in performing and maintaining Failure Modes Effects Analysis (FMEA).
  • Hands-on, demonstrable work experience with writing technical documentation.
  • Demonstrable work experience in test method validation techniques.
  • Certified Quality Engineer (CQE) preferred.
  • Proficient (or better) computer skills, including Excel and Word.

Personal Attributes:

  • Meets EG-GILERO Core Values:
  • Open Communication
  • Accountability
  • Customer Focus
  • Innovation
  • Efficiency
  • Excellence
  • Integrity
  • Comfortable and productive in a fast-paced, entrepreneurial environment.
  • A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients.
  • Commitment to excellence and quality service to external and internal customer.
  • Commitment to established policies and procedures, while contributing to continuous improvements.
  • Excellent communication skills (oral and written).
  • Efficient time management skills with the ability to work within established budgets and deadlines.

Job Type: Full-time