Production Controls Consultant
6+ months contract to start with (extendable)
The Production Controls Consultant will be part of the Philips Andover Quality Transformation group and report to the E2E Project Manager (Risk Management), Systems Engineering Manager. The position will focus on E2E production controls and risk management engineering activities.
This Production Controls Consultant will be responsible for the technical leadership and acceptability of the application of the Philips Risk Management Process. The scope includes ownership of the risk management process and procedures, identify need and support training activities for the effective application of the risk management process, lead risk management activities and act as technical liaison to the risk management process, support BUs in requirement management and design specification activities, identify and facilitate the process interfaces, enable design reviews and coordinate risk management file reviews.
This is a key and critical role within the Risk Management Group within Philips Monitoring Analytics & Therapeutic Care (MA&TC). This is an opportunity to become part of a well-seasoned winning team that owns the risk management process and supports its effective deployment for all MA&TC medical devices / products. The risk management team plays a very important role in ensuring products designed by Philips are of the highest quality and meet all applicable international standards. Your responsibilities will include, but not limited to the following:
• Define and shape the End2End Risk Management processes
• Lead and support the safety and quality vision embedded in the risk management process to Philips BUs and team members.
• Provide support for the application of the risk management process to all Philips BUs, identifying the interfaces between the functional areas involved in the creation and sustainability of medical devices that are safe and effective.
• Act as technical liaison to cross functional teams in the implementation of the risk management process.
• Support the BUs in translating safety/reliability/quality requirements into Production Control measures by means of the use of system engineering methodologies.
• Provide technical depth of knowledge in system engineering tools and methodologies like dFMEA/pFMEA, DfX (DfM, DfA, DfS, DfT, DfV), APQP, IQ/OQ/PQ, Control Plan, SPC, Measurement System Analysis, CTQ/CTS
• Support site wide training on risk management and product reliability/quality best practices.
• Lead and drive continuous improvement of Manufacture Testing and Processes (Risk-based testing)
• Lead and coach Design Transfer into production process using risk-driven approach
• Lead and drive in planning and execution of production control risk management activities
• Provide technical support and foster a culture of effective Risk Management practices
• Provide technical depth of knowledge in Risk Management standards and processes, as well as production controls in supporting of the implementation of End2End Risk management activities.
• BSEE /MSEE (or equivalent engineering degrees) with minimum of 15 years of experience in new product introduction (NPI) of complex products, preferably in the medical industry
• Demonstrate the ability to lead, communicate, interact and influence effectively at all levels across functions and business units
• Demonstrate the knowledge of all manufacturing phases from process specification creation thru post release process monitoring
• Demonstrate the knowledge of production tools such as SAP, eDMR, CAPA, etc
• Demonstrate the ability to lead projects including process changes in production environment
• Application knowledge of design controls and risk management processes in compliance with ISO 13485 and EN/ISO 14971 standards and global regulations (i.e. FDA, EU, CFDA, etc.).
• Experience with FMEA, APQP is highly desirable
• Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions.
• Demonstrate competence in the use of system engineering tools and methodologies.
• Highly passionate and positive infectious attitude who strives for high performance and product safety and quality.
• Ability to effectively implement continual improvement to increase effectiveness of the risk management process.
• Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project and PowerPoint.
Excellent English skills, written and speaking.
Thanks and Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com