Senior Quality Engineer-Remote

Our client a startup medical device company currently seeks a Senior Quality Engineer to join their team. Reporting to Quality Engineering Manager the Senior Quality Engineer is responsible for Design Assurance and Quality Engineering support for the company’s novel medical device products. This role shall support the Quality Engineering Manager for Quality Assurance and Quality Control activities related to development, manufacturing, release, and testing of medical device products in compliance applicable device and drug regulations and standards. This role is virtual position but will require travel to contract manufacturers from time to time

Role/Responsibilities

• Provide Quality Engineering support in successful transition from development and clinical production activities to commercial manufacturing using design and manufacturability concepts, including statistical techniques.
• Assist in the development and implementation of validation and inspection methods to analyze and assure product quality based on sound statistics.
• Assist in quality engineering activities at contract manufacturing organizations (CMO) from receiving to final release, including but not limited to, training, validation, and continuous monitoring of product/process performance.
• Supports Quality oversight of drug substance and drug product CMOs as well as analytical laboratories, as needed.
• Performs disposition of batch production records, supports the conduct of internal and supplier quality audits and proactively manages issues and risks to company goals and objectives.
• Participates in audit readiness activities for mock audits, FDA pre-approval inspection and commercial launch of the drug product.
• Manage and conduct root cause investigations and corrective actions for nonconformances for quality issues, product design, and manufacturing & testing processes at contract manufacturing organizations.
• Responsible for working with R&D and Operations including supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485, 21 CFR 820, 4, 210, 211, and other applicable standards and regulations pertaining to products.
• Collaborate with Regulatory Affairs and cross functional teams to ensure appropriate execution of development and validation strategies and preparation of risk assessments as needed.
• Review and approve method validations, change control, CAPA, deviations and investigations, in collaboration with CMOs.
• Assist business partners to ensure that process development, manufacturing, scale up and project timelines are consistently met per corporate objectives.
• Contribute to the successful execution of departmental and company goals.
• Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
• Assist in technology transfer to partner or contract manufacturing organizations, as applicable.
• Support and/or lead activities related to the Post-Market Surveillance program, compiling data across departments to develop PMS plans and reports.
• Promote and support a quality and continuous improvement culture.
• Other miscellaneous projects/activities as assigned.

• Bachelor’s degree in Engineering or related technical specialty.
• Quality engineering related professional certification a plus.
• 6+ years of experience in design/manufacturing quality engineering in the medical device industry (catheter experience preferred). Familiarity with drug-device combination products and/or drug products a plus.
• Experience in planning and conducting product and process activities in compliance with FDA 21 CFR 820, MDD, MDR, ISO 13485 & 14971 and other applicable regulatory requirements.
• Provided Quality oversight and guidance for cross-functional technical projects pertaining to the device product.
• Experience with writing/editing/reviewing effective procedures and technical documents.
• Experience with development, clinical, and commercial product release activities.
• Experience with root cause investigations and corrective actions.
• Experience in the oversight and management of contract manufacturing organizations.
• Experience with Post-Market Surveillance plans and reports.