The Sr Quality Engineer I (SQE) will be responsible for developing, facilitating, maintaining and improving Quality System of Silicon Valley Labs (SVL), a division of Terumo Medical Corporation, in accordance with applicable quality systems and regulatory requirements. At a minimum, this includes compliance to the FDA’s Quality System Regulation/Current Good Manufacturing Practices (21 CFR Part 820), ISO 13485, Medical Device Directive and ISO 14971. The SQE will drive Quality System improvements companywide ensuring policies, procedures, and standards are current, compliant and addressing the needs of the business.
The SQE will also be responsible for developing and sustaining internal processes key to optimal performance of the Quality Management. Other quality system functions will be included upon growth of the business.
The SQE will collect and manage data and information, including audit findings, customer complaints, and customer surveys, necessary to assess the performance of the QMS. This scope includes analyzing key metrics for trends indicating the effectiveness of the QMS, making recommendations regarding system improvements and facilitating the training required to implement the improvements. The SQE will monitor, analyze, and report Quality Management System metrics to Senior Management, Management Representative, and key clients.
This role will support Manufacturing including outsourcing to contract manufacturer(s), Design documentation in collaboration with R&D, Supplier management, Management Reviews. The SQE will support and participate in cross-functional projects when assigned, facilitate technical innovations to support business goals and assist with other Quality System activities as requested by management. In summary, the SQE must support the development of a quality/business culture throughout SVL that is based upon effective compliance and continuous business improvement.
- Responsible for leading and managing outsourced manufacturing of new products through close communication with internal departments (QA, Operation, and R&D) and contract manufacture(s). This responsibility includes initiation and/or review of quality documents (SOPs, MPIs, specifications, validation protocols/reports, supplier quality agreement, and other documents), Management of the Supplier Corrective Action Request process.
- Supplier management activities.
- Lead/review of all manufacturing-related supplier add requests for impact on quality system and required controls
- Build relationships with suppliers to ensure that purchased components meet specifications.
- Drive continuous improvement in supplier performance through utilization tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
- Optimize process capability on significant characteristics through effective application of statistical analysis techniques and training of Suppliers in problem-solving. Provide expert analysis, guidance and support to Suppliers in Process Improvement.
- Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action.
- Drives Supplier actions to verify component and process quality at the Supplier’s location to reduce the need for incoming inspection activities.
- Manage the Supplier Corrective Action Request process.
- Assist in the development of dFMEA (Design Failure Mode Effect Analysis) and pFMEA (Process Failure Mode Effect Analysis) and control plans where required.
- Trending of supplier metrics
- Maintain and analyze Key Performance Indicators (KPIs) and Cost of Poor Quality data to identify recurring trends and drives improvement actions to reduce internal and external failure costs.
- Work with suppliers and Supply Chain to establish and manage continuous improvement programs including supplier ratings and supplier score cards.
- Manage databases and files containing information supporting the suitability of suppliers to provide components and services. Maintain accessible records for internal and third-party audits.
- Generate a monthly Supplier Performance Report including input from discrepancy reports and supplier ratings.
- Lead manufacturing transfer from contract manufactures to other manufacturing sites (in future).
- Responsible for facilitating efforts to plan, implement and maintain a plan of action to revise the existing Quality System in accordance with compliance requirements and the strategic needs of the business.
- Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR Part 820), ISO13485: 2016, European MDD / MDR, and all other applicable regulations.
- Facilitate the incorporation of a process risk management procedure that defines the incorporation of a risk-based strategy for process changes, development, validation and continuous improvement.
- Promotes and audits corrective actions and continuous improvement efforts for quality management systems.
- Make recommendations regarding system improvements and training required to implement the improvements.
- Emphasize the awareness of quality system requirements, processes and deliverables throughout the organization.
- Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating and incorporating any observations, nonconformances, opportunities for improvement and potential gaps/preventive actions.
- Develop, administer and continuously improve the training required to support the effectiveness and suitability of the quality system. This requirement includes the development, implementation and maintenance of cGMP Compliance, Good Documentation Practices, and compliance Process Development.
- Provide practical, useful and effective quality systems reports for senior management, management reviews, business strategic initiatives and specific requests.
- Support failure investigations and product complaints closure
- Complete other responsibilities as assigned.
Knowledge, Skills and Abilities (KSAs)
- Knowledge of medical product manufacturing and development: 21 CFR 820 (Quality System Regulation), 21 CFR 803 and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE.
- Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications and drawings.
- Thorough working knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, etc.).
- Understanding of CAPA and closed loop corrective action.
- Proficiency in Microsoft Office applications as well as other Document Control software applications.
- Ability to interact effectively (both verbal and written) with associates across all departments within an organization at all levels.
- Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail
- Must have demonstrated initiative and ability to work independently while handling multiple tasks.
- Strong written, verbal and interpersonal communication skills
- A 4-year degree in engineering, scientific discipline, or similar.
- Minimum of 7 years of experience of involvement and/or management of manufacturing of Class II or III medical devices
- Experience in working with suppliers including contract manufacture(s) on medical product quality issues, including supplier evaluation and on-site auditing.
- Experience in writing SOPs and/or other documents.
- Experience in document control, equipment management, and/or supplier management. (Preferred)
- Certification as a Quality Engineer or Quality Auditor by the American Society for Quality. (Preferred)