Job Description

The Quality Assurance (QA) Software Engineer is responsible for providing compliance and regulatory support to all aspects of the organization. The QA Software Engineer will work closely with the IT, Platform Development and Computer Vision departments to provide guidance and direction to meet the applicable requirements in IEC 62304, FDA regulations and other ISO standards.

This position will ensure Epic software is developed, documented, validated, released, and maintained appropriate to its risk level. In addition, this position will support all aspects of Quality as needed. This person will be organized, self-motivated and have strong oral and written communication skills as they will work closely with internal customers to draft or revise documents and procedures.

ELEMENTS:

EDUCATION/EXPERIENCE: B.S. or higher in a related field; 1-5 years of experience in Quality in a regulated environment (ex: CLIA, FDA, or ISO lab) and a minimum of 3 years Software Development/Quality Engineering experience. Hands-on experience with 21 CFR Part 820, 21 CFR Part 11, IEC 62304, ISO 14971, and ISO 13485. Current ASQ-CSQE is a plus.

COMMUNICATION SKILL: Clear and accurate written and verbal communication. Works effectively with both internal and external audiences to analyze, interpret, and summarize data both orally and in writing. Possess ability to write detailed protocols and procedures and SOP's, and draft detailed reports for internal and external communication of progress and results.

INTERPERSONAL SKILL: Works effectively both as an independent contributor, a team member, and a champion for quality; can manage relationships with internal and external “customers” effectively.

JUDGMENT: Ability to design and implement quality-related qualitative and quantitative reviews and analyses; prioritize work and meet multiple deadlines, ability to work with significant independence. Effective time management skills.

EXECUTION: Highly efficient at multitasking; able to help the group to set priorities to accomplish complex tasks; ability to troubleshoot problems and generate effective solutions with appropriate quality tools.

ESSENTIAL FUNCTIONS:

• Responsible for the Quality review and approval of Epic developed software; platform development and algorithm development.
• Provide guidance and direction to ensure software development meets applicable requirements in FDA regulations, IEC 62304, ISO 13485, and ISO 14971.
• Review and provide input on software development planning, tool qualifications, risk assessments, designs, requirements, test cases, test protocols, and test results.
• Quality point of contact for software development projects and monitors/assesses every phase of software development process. Updates and coordinates with all Quality personnel to ensure alignment or implementation of software changes.
• Responsible for reviewing and approving change controls, document revisions and implementation plans to support software implementation.
• Providing support for the Quality department Quality Engineers, QA Specialist and Doc Control Specialists.
• Approving Equipment IQ/OQ/PQ protocols & reports, use logs, calibration logs, maintenance logs, and maintaining equipment files.
• Performs General Quality activities:
  • Analyzing Quality metrics, identify trends/improvement opportunities and present data to Quality Management and Management Review meetings.
  • Supporting for the Compliance program including assigning and approving Deviations, Nonconformance reports, CAPAs and Audits.
  • Tracking to completion all corrective action activities.
  • Participating in Quality audits for the internal audit program, external audits (suppliers) or 3rd party audits by Sponsors.
  • Generating procedures and forms as necessary to support the Quality Management system.
  • Maintain accurate and detailed records in accordance with GLP, GCP and CLIA regulations.
  • Must understand and demonstrate compliance with all applicable regulatory requirements.
• Responsible for supporting a positive, professional, team-oriented, harassment-free work environment by understanding and complying with the Employee Handbook and Safety Policy/Manual and all Human Resources policies, and by demonstrating the Company’s values and being a role model for the Company Brand.

ADDITIONAL DUTIES:

May perform additional duties as assigned or directed by management from time to time.

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