At Jabil, we empower the brands who empower the world – it’s our reason for being and the guiding force that’s driving us to become the most technologically advanced manufacturing solutions provider on the planet. Whether we’re serving one of the world’s biggest and best known brands or the coolest tech startups, our resolve never wavers. We share common desires with these brands: to make the world a better, safer and cleaner place.
Managing the Document Control, CAPA, Complaint Investigation, Management Review, and Audit Management processes and systems for the Manufacturing Operations sites. Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NCR system indicator .
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Know and follow local and global policies and procedures; ensure that direct reports know and follow policies and procedures related to work activities performed in area of responsibility
- Complete training in area of responsibility and ensure that direct reports are trained in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training and ensure that required periodic re-training takes place for direct reports in areas such as safety and environmental
- Set standards for safe behavior. Recognize and reward safe behavior in others.
- Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance and ensure that safety is a part of each direct report’s goals and objectives.
- Provide resources (time and money) necessary to maintain safety process. Ensure safety structure is in place in form of working committees and department coordinators
- Own the customer complaint handling and CAPA processes and systems for the Brandywine and Wilson Drive sites. Responsibilities will include oversight of owner assignment, root cause analysis, CAPA plan development, and verification of completion/effectiveness while owning the overall timeliness of site CAPA activities.
- Represent the sites on the world wide quality systems teams.
- Work effectively with other NCR / CAPA site leaders to ensure consistent systems and processes across Jabil Healthcare.
- Drive the improvement and development of quality systems for the facilities.
- Responsible for the overall management and effectiveness of quality systems, including leading and facilitating of relevant data review forums.
- Provide education and mentoring as needed regarding CAPA (beginners and continuous education).
- Develop and implement measures to monitor the effectiveness of the CAPA system.
- Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NCR system indicator.
- Manage and become subject matter expert for change control activities and systems including but not limited to ADAPTIV and Windchill. Lead document control team and activities.
- Serves as the initial point of contact for Product Complaints / Product Quality issues and ensures Risk Assessment is timely and adequately addressed.
- Support sites risk management process.
- Oversees the complaint product evaluations activities for the sites, and maintains track and trending of product performance / results of product evaluations for escalation to CAPA.
- Establishes and maintains objectives, programs, procedures and controls to support the quality policy and mission.
- Oversee capital related projects and monitor controllable spending for the department.
- Lead or participate in regulatory agency interaction: FDA (Food & Drug Administration), TUV, J&J CQA during audits or other information inquiries.
- Provide for associate development by setting standards, managing expectations & coordinating training programs.
- Evaluate and recommend staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
- Assist with problem solving, decision-making & conflict resolution through coaching & counseling.
- Partner with cross-functional leaders to meet goals and objectives.
- Assure that internal manufacturing facilities, component suppliers & external manufacturers have strong, capable quality systems & are in compliance with government & corporate regulations.
- Lead efforts to increase the proficiency (skills and knowledge) of the organization through attainment of PE, and professional certifications.
- Lead Management Review process, develop metrics and measures, and drive Plant/Organizational initiatives driving business performance.
- Follow Records management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records, Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
- Other responsibilities may be assigned & not all responsibilities listed may be assigned
Management & Supervisory Responsibilities:
- Job is directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
- QSR, ISO and other regulatory requirements knowledge, required.
- Background in FDA regulated industry, preferred
- Demonstrated project management skills with strong results orientation, required.
- Direct interaction and experience with the US FDA or Notified Bodies during audits/investigations preferred.
- Strong communication, influencing and presentation skills, required.
- Knowledge or completion of Process Excellence Six Sigma, Lean, and/or Design
- Excellence courses or a comparable process for problem solving/ decision making preferred. Green or Black Belt Certification highly desired.
- Supervisory skills, preferred.
- Experience Leading CAPAs, required.
- Experience with Management Review. Complaints, Non-Conforming Materials, and , Document Controls sections of Quality Systems Regulation, preferred.
- Experience with external auditing bodies, preferred
- Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software, database management & desktop publishing.
- Networked environment experience
EDUCATION & EXPERIENCE REQUIREMENTS
- B.S. degree in engineering or science, required.
- Advanced degree, desired
- Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills, Black belt preferred
- CQE (Quality Engineer Certification), CQA (Quality Auditor Certification), CQM (Quality Manager Certification), Certified ISO (International Organization for Standardization) auditor, desired.
- 5 years in quality systems management is required.
- Experience in medical device or pharmaceutical industry preferred
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.