Senior Quality Engineer I - Software

MAIN JOB RESPONSIBILITIES / COMPETENCIES

• Coordinate quality engineering activities supporting the Software as a Medical Device (SaMD), Quality System software, and Manufacturing software platforms to achieve business objectives.
• Provide technical expertise through the software lifecycle, with a focus on SaMD, in the following areas: design control, risk analyses, verification/validation strategy, maintenance and change management.
• Develop strategy as part of cross-functional teams to support the compliant and effective release of SaMD and other software applications.
• Provide guidance and leadership on development / review of design control and validation policies and procedures, and resolutions to quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Provide technical expertise to the risk documentation process.
• Provide guidance and leadership on investigations involving software nonconformances, product or component failures, or customer complaints by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA.
• Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
• Provide guidance and leadership on design processes and site engineering functions to identify critical parameters and improve process quality.
• Participate on Design Control New Product development teams; advise the team on design control requirements; develop, review and approve design control deliverables related to quality engineering and validations.
• Other duties as assigned.

REQUIREMENTSEDUCATION & TRAINING

• Bachelor’s degree, preferably in Engineering or sciences.
• Advanced degree preferred.
• Certified Quality Engineer (CQE) or equivalent preferred

EXPERIENCE

• Five years’ experience in validation and/or design control in the medical device software industry, including the practical application of FDA Quality System Regulation and ISO 13485; or equivalent combination of education/experience.
• Experience in medical device software change management required.
• Experience in vision care or intraocular lens industry preferred.
• General knowledge of medical device software requirements (IEC 62304, IEC 82304) required.
• Knowledge of international/ISO standards on ophthalmology preferred
• Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.

SKILLS

• Experience in writing technical documents, especially compliance and/or validation/quality assurance documents and protocols required.