Principal Quality Engineer

Principal Quality Engineer (Software)

Type: Hybrid (2 Days on Site per week)

Industry: Medical Device (medical device experience not required)

The Principal Quality Engineer ensures new or modified software products conform to requirements and establish compliance with the quality system. You will assist our client transferring from XA to JDE.

You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by ensuring minimum standards are met for verification and validation activities and meeting business needs.

Principal Duties and Responsibilities

• Provides technical and quality system guidance related to establishing software requirements.
• Supports software verification and validation activities for new products in accordance with design planning procedures.
• This includes, but is not limited to, review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
• Participates in the planning and continual improvement of the system and its documentation.
• Formulates procedures, specifications, and standards for products and processes.
• Develops and implements corrective/preventative action plans.
• Performs risk evaluation and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.
• Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represents the quality engineering function for the review and approval of designated design outputs.
• Supports non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
• Involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
• Drives best practices for establishing requirements and completing design verification and validation especially as it relates to user needs and cross-functionality between systems.

Education/Experience Requirements

• B.S. in engineering and Software Validation experience preferred
• 7 years of experience preferred
• QMS document experience (any amount is fine)
• Change control experience. If owned it, 2-3 years is suitable. If took part in it, 5 years required.
• 5 years of Engineering experience (ideally in a highly regulated related industry)

Preferred Requirements

• Experience in medical devices preferred but not required
• Software Validation
• Previous Migration experience
• JDE or XA exposure
• Certification as a Quality Engineer (CQE) or Certification as a Reliability Engineer (CRE) issued by the American Society of Quality (ASQ)