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.

Jabil Brandywine campus is located in West Chester, PA. We are proud to manufacture Medical Devices for orthopedic specialties including trauma, spine, and specialty implants for leading medical technology companies. Our employees are honored to work together with industry leading companies to make a difference in the lives of patients around the world.

JOB SUMMARY

This position has the responsibility and authority to lead assigned Quality System processes. In addition this role will lead internal audits, customer audits, ISO Registration audits, FDA Inspections and when required prepare submissions and responses to FDA and ISO Registrars. This position will serve as the primary contact for site departments, business units, and corporate functions and will work closely with direct reports to provide guidance and development opportunities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

·       Leading internal audits and supplier audits,

·       Leading the readiness program for ISO Registration audits, FDA Inspections and customer audits

·       Preparing submissions and responses to FDA and ISO Registrars

·       Acting as the primary compliance contact for site departments, business units, and corporate functions

·       Acting as a subject matter expert for the Quality Systems and Compliance programs.

·       Ensuring the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, Anvisa)

·       Supporting the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.

·       Performing all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements

JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

·         Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
·         Some experience with compliance assessments, gap assessments and risk management assessments.
·         Experience with program change management practices, lean or six sigma, program and system integration efforts
·         Strong computer skills; Word, Excel, PowerPoint
·         Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally.
·         Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment, influence change without alienating others.
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EDUCATION & EXPERIENCE REQUIREMENTS

·         Bachelor’s degree required (Quality, Regulatory, Engineering, Business or Life Sciences)
·         Master’s degree is desired (Quality, Regulatory)
·         6 + years of industry experience within Quality and/or Regulatory, and managing high performing teams.

·       Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)

·       Experience with compliance assessments, gap assessments and risk assessments.

·       Experience with program change management practices, lean or six sigma, program and system integration efforts

·         Or a combination of education, experience and/or training.

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.