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.
Descripción del Trabajo
To perform internal and supplier audits, participate in external audits, and provide support to the site, as well as the broader Compliance Team, in relation to execution, monitoring and compliance to applicable procedures, regulations, standards, and Jabil Healthcare requirements.
High school diploma, College Degree or equivalent desired.
ASQ Certification (CQA) or MD Lead Auditor Certification desired.
KEY SKILLS/KNOWLEDGE REQUIRED:SKILL SETS
Knowledge of product and processes.
Knowledge of test and inspection methods.
Knowledge of quality records, ERP systems, labeling and operational computer systems is preferred.
Knowledge of medical devices preferred.
Proficient with Good Manufacturing Practices (GMPs) and ISO standards and regulations is required.
Strong computer skills and use of software applications.
Four to six years of experience with manufacturing operations, preferably in the medical device or other regulated industry.
One to three years of Quality Assurance, Regulatory, or Compliance experience is preferred.
KEY JOB RESPONSIBILITIES:
Lead and/or execute internal and supplier audits to assess compliance to FDA, ISO, and Jabil standards and requirements.
Participate in and support audits performed by FDA, Registrars, Customers, and other external agencies.
Participate as directed in identifying issues and determining corrective actions in relation to applicable regulations, standards, and Jabil requirements.
Support the maintenance of department metrics, periodic reports, and data analysis.
Follow Jabil 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.
Provide support to development, validation, deployment, and maintenance of quality computer systems to ensure compliance to regulatory bodies.
Provide leadership of activities and serve as a resource for quality and compliance issues and initiatives.
Provide coaching and mentoring of Audit, CAPA, and NCR activities. Work cooperatively toward effective outcomes.
Provide training on quality computer systems and compliance topics under the direction of the compliance organization.
Coordinate discussions with Quality, Engineering, Work Cells, and other business partners to ensure Compliance objectives are met.
Partner with Quality, Engineering, Work Cells and other business partners to develop corrective actions for recurring problems, through the use of quality principles and data.
Write and execute protocols and reports as necessary.
Conduct statistical analyses, including but not limited to GR&R, Capability, FMEA, and SPC, as required.
Provide support as needed to manufacturing operations to determine the root cause of issues.
Maintain knowledge of all procedures, changes to specifications (Process, Training Manuals, Material Specifications, etc.), and regulations related to their area of responsibility.
Maintain process knowledge for the assigned area of responsibility.
Work with QA Engineers on document and process improvements, including but not limited to data collection, change processes, and additional training, as required.
Provide materials/communication or service to customers in a timely manner.
Recommend and implement revisions, corrections, and changes to procedures, methods, and computer systems.
Provide leadership and initiative to the organization through continuous improvement projects.
Provide necessary feedback to customers.
Coordinate discussions with business partners regarding compliance, quality issues, projects, and activities as required.
Exercise initiative and ingenuity to deal with varying circumstances and changing conditions, referring unusual situations to the appropriate facility leadership.
Provide leadership with project completion and project enhancements.
Work cooperatively toward effective outcomes.
Work to resolve differences in a collaborative effort.
Follow all company safety policies and other safety precautions.
Promote safety to all associates.
Attend required safety training.
Follow all applicable EMS procedures.
Adhere to the site’s EHS Code of Conduct.
Other responsibilities may be assigned and not all responsibilities listed may be assigned.
POST HIRE TRAINING PLAN REQUIREMENTS:
Maintain consistent and timely adherence to position training curriculum.
Requires occasional long walking, standing, bending, stooping, and reaching.
May require lifting of boxes or material not to exceed 50 lbs.
Office deskwork, requiring sitting, walking, using the phone and computer.
Work in office and/or manufacturing environment and/or laboratory environment.
Flexibility to adjust and rotate the working hours to support Manufacturing needs.
Gowning required as per established procedures.
Little to no travel required. Passport may be required.
This description is representative of the knowledge, skill and ability necessary to carry out the requirements of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties of the job.
The anticipated hourly pay range for this role is $19.00 to $24.00.
Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, education (if requirement noted above), geographic location, external market. As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purpose plan; and paid time off. data, and consideration of internal equity.
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 the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
The anticipated hourly pay range for this role is $15.11 - $21.90 - $28.70. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, education (if requirement noted above), geographic location, external market data, and consideration of internal equity.
As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purpose plan; and paid time off.