SomnoMed® is a global medical device company, founded in 2004 and listed on the Australian Stock Exchange, operating in 28 countries. With headquarters in Sydney, Australia, and offices in Europe and the United States, SomnoMed® specializes in developing and manufacturing clinically proven medical devices for the treatment of Obstructive Sleep Apnea (OSA). Our oral appliances have successfully treated patients worldwide with mild and moderate OSA, providing comfortable and effective solutions.

SomnoMed® is a leader in developing OSA devices, with each appliance custom-made using state-of-the-art technology to deliver precision, comfort, and first-time fit solutions. We are committed to continuous improvement, ensuring that our oral sleep medicine devices are highly effective and comfortable. Our devices have received FDA 510(k) clearance and are manufactured in accordance with ISO 13485 quality standards.

The Senior Quality Engineer provides advanced quality engineering expertise, encompassing comprehensive risk management, protocol and report generation/review, to ensure compliance to internal quality system procedures and industry best practices within the medical device industry. This role focuses on technical proficiency in quality management systems, process improvement, data analysis, risk management, and protocol/report generation/review to support product development, manufacturing, and distribution.

Job Descriptions:

Quality Management System Support

• Contribute significantly to the maintenance and improvement of the Quality Management System (QMS)
• Conduct in-depth investigations and implement effective CAPA actions
• May participate or lead Internal Audit Activities and provide support during external audits

• Protocol and Report Development and Review

• Generate and review protocols for verification and validation, process validation, and process improvement feasibility studies
• Ensure protocols include appropriate sample sizes and acceptance criteria based on identified risks and statistical justification
• Generate and review comprehensive reports summarizing the results of verification, validation, process validation, and other quality-related activities
• Collaborate with cross-functional teams to develop robust and scientifically sound protocols and reports
• Analyze and interpret validation and verification data, and provide recommendations based on the results, documented within the reports

Risk Management:

• Contribute to the development, maintenance, and improvement of the risk management process
• Maintain and update risk management documentation, including FMEA, risk management plans and reports
• Monitor and evaluate the effectiveness of risk control measures
• Contribute to the risk management portion of change management, verification and validation, and other activities that necessitates risk assessment

Technical Manufacturing Quality Oversight

• Offer quality engineering support to manufacturing operations
• Conduct reviews of manufacturing documentation, as necessary
• Lead investigations of non-conformances and deviations
• Perform data analysis to drive process optimization

Quality Check (QC)

• Incoming Quality Checks, In-Process Checks, and Final Quality Checks - for the raw materials, components, processes, finished devices and finished goods that are in the Pre-Production Stage.

Qualifications:

• Bachelor’s degree in engineering (Mechanical, Chemical, Bioengineering) or scientific discipline (Biology, Chemistry, Microbiology). A master’s degree is a plus.
• A minimum of 10 years of direct quality engineering and/or quality assurance experience in the medical device industry is preferred.
• Familiarity with medical device regulations (21 CFR Part 820), MDD, quality management system (ISO 13485), and other medical device-related ISO standards (ISO 14971, ISO 10993, IEC 60601).
• Proficient in quality management system processes including but not limited to management responsibility, document control, design control, supplier management, CAPA, internal audits, IQ, OQ, PQ, production and service provisions.
• Software Validation and Design of Experiments (DoE) experience a plus
• Certified ISO 13485 lead auditor a plus.

Please refer to job description.