At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
Primary responsibilities include managing regulatory compliance of quality system in accordance with ISO13485, FDA 21 CFR Part 820 and customer specific requirements. Provides quality assurance for product design and development project and managing internal, customer, third party quality system audits. Review and assist with Design History File and other project support documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Establish, implement, maintain and improve quality management system.
- Maintain quality system documentation, plan quality system process, and implement internal quality audit.
- Support external audit, such as customer audit, third party audit, FDA factory inspection.
- Develop and maintain project quality assurance plans and monitor product design project execution from quality perspectives.
- Support the engineering team in the management and maintenance of design history file.
- Provide direction and training to the employees on quality regulatory requirements
- Be responsible for corrective and preventive actions and customer complaints.
- Provide professional support on quality issues with the internal/external customer as needed.
- Work with design engineering team, manufacturing, and project manager on quality aspects.
- Prepare and present presentations related to quality improvement initiatives.
- Provide regular updates to Quality Manager on the execution of quality assurance activities and highlight the risk with solution.
- Comply and follow all procedures within the company security policy, environment, safety and health rules and regulations associated with this position.
- May perform other duties and responsibilities as assigned.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
- Typically reports to Management. Direct supervisor job title(s) typically include: Quality Manager
- Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
- Familiar with Quality Management System Standards and Regulations, 21CFR Part 820, ISO13485, ISO9001
- Familiar with the document control system and able to comprehend and implement changes.
- Familiar with the overall quality management system procedures.
- Familiar with problem solving and risk management knowledge, 8D, CAPA, FMEA, ISO14971
- Team player and flexibility to deal with ongoing change and challenge.
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
- English communication both orally and in written.
- Organize verbal and written ideas clearly and use an appropriate business style and quality thinking.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor’s degree in quality management and/or Science/Engineering discipline.
- At least eight years working experience in Quality Management related field.
- Prefer experience in medical device manufacturing and automotive manufacturing.
- Experience in creating and implementing quality system and/or quality system audit.
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.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.
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 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.