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.

Hybrid remote and onsite role, expectation of 1-2 days onsite at Elmira, NY Plant.

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.

Must be able to report in person to the Elmira, NY plant 1-2 days a week to support job duties.

This job cannot be performed remotely in the state of Colorado.

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.