Descripción del Trabajo
This position will be responsible for identifying opportunities to improve the Quality Management System and ensuring effective and sustainable implementation of those improvements primarily in Asia. The position is also responsible for conducting Global Internal ISO 9001 Audits as well as ensuring an effective close loop process within the Cross Site Preventive Action System.
This role also partners with Jabil Regulated Industries (JRI) to provide subject matter expertise in interpretation and practical application of FDA and international medical regulatory requirements, quality management systems and quality assurance programs. This position will assist in the development, creation, and documentation of world class quality and business system improvements, as well as support for customer and/or ISO/FDA escalations and FDA QSIT inspections as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide QMS governance over a Region and ensure 0 QMS breakdowns across sites
- Drive cross site corrective and preventive actions across Jabil operations regionally.
- Review site corrective action, facilitate effective root cause analysis and 8D implementations, coordinate the sharing of best practices and the execution of the preventive action in all applicable operations regionally
- Propose, facilitate and execute new quality methods to establish Quality as a competitive advantage
- Define, develop, and implement Global corrective and preventive action strategies that contribute to business development and strategic directions
- Report on regional CAR and Audit metrics
- Perform global internal audits on operations and business processes to verify: Quality Management System is effective and continually improving; effectiveness sustainability of critical corrective and preventive actions; and cross site preventive actions and best practices are effectively implemented across the business
- Engage with the business and operations teams on customer quality resolutions and ensure best practices are fanned out throughout all applicable sites
- Define and implement the most efficient quality processes and tools across the region
- Establish and maintain a consistent and effective regional auditor pool
- Implement the global internal auditor training program within region
- Partner with sites to drive robust systemic solutions to audit findings
- Evaluate critical audit findings for potential Cross Site Preventive Actions to proliferate solutions across Jabil
- Comply and follow all procedures within the company Quality Management System and security policy.
- Partner with JRI to support the EMS medical workcells
- Provide subject matter expertise (SME) in the development and implementation of ISO9001, ISO13485, FDA 21CFR Part 820, SFDA, MHLW, ANVISA and other standards (domestic or international) relevant to the medical sector. To become familiar with other standards as applicable.
- Ensure functional management and business management are aware of and understand the principles and expectations associated with the above-mentioned standards through training
- Act as a facilitator to Jabil management in the standardization and simplification of the standards. This will include not only auditing and training of the system but offering interpretation of standards and suggesting means / methods of improving elements and practices within the system.
- Implement effective, compliant quality systems and development of standards related to design and software control.
- Work with sites to identify and close compliance gaps
- Ensure sites with FDA registered product are FDA QSIT ready
- Participate in all FDA QSIT inspections
- Travel globally approximately 50% to enable on-site support, training, auditing. Primarily Asia, but also the EU, USA, and Mexico
- May perform other duties and responsibilities as assigned.
LEADERSHIP AND MANAGEMENT RESPONSIBILITIES
Employee and Team Development:
- Assist QS & Compliance managers to create and/or validate training curriculum in compliance with medical requirements.
- Coach and mentor Jabil sites to deliver excellence to internal and external customers.
- Establish clear measurable goals and objectives by which to determine individual and team results (i.e. operational metrics, results against project timelines, training documentation, knowledge of operational roles and responsibilities).
- Solicit ongoing feedback from business units for effectiveness of support
- Provide ongoing coaching and counseling to team members based on feedback.
- Drive self to continuously improve in key operational metrics and the achievement of the organizational goals.
- Assist to coordinate activities of medical initiatives as required and keep focused in times of crises.
- Establish strong relationship with Quality SVP, BU team, Ops VPs, Site Ops Mgr and site RA/QA Mgr
- Assist to establish process to share Best Practices and Lessons Learned
- Organize verbal and written ideas clearly and use an appropriate business style.
- Able to switch communication style to an internal consultant when presenting audit findings to stakeholders.
- Focus communications meetings on enhance the continual improvement efforts.
Business Strategy and Direction:
- Know and understand regulatory standards and compliance requirements at expert level. Must be an expert in class I, II, and III medical device manufacturing and submission requirements
- Align activities such that they serve to check and validate overall quality & business strategies implemented.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
- Typically reports to Management. Direct supervisor typically includes: Director of Quality Systems
- No management of direct reports
- This is a hands-on role, which requires an energetic and motivated self-starter with a passion.
- Hands on experience in Surface Mount Technology and assembly manufacturing
- Extensive understanding and working knowledge of ISO9001, ISO13485 and FDA Regulations QSR/21 CFR 82, and international regulatory requirements such as SFDA, ANVISA, MHLW, EU Directives.
- Previous class I, II, and III submission experience required.
- Understanding of risk analysis using FMEA and other techniques.
- Experienced in planning and executing software validation for medical device and manufacturing processes. (Experience in system validation compliant with 21CFR part 11)
- Extensive experience in tools validation
- Understanding of medical device compliance issues and regulatory submission requirements.
- Practical experience in deploying Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP)
- Experience with registration/listing of products with FDA and in various countries as well as “Technical File” creation and CE marking of products.
- Experience with Reduced-Risk Product (RRP) a plus
- Strong and convincing communication and influencing skills.
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor's Degree required.
- Degree in Business Management preferred.
- Minimum of 7 years work-related experience required, preferably in Healthcare Quality Systems
- Participation in the front room for a minimum of 5 FDA QSIT inspections
- Or a combination of education, experience and/or training.