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Regulatory Compliance Site Lead

Req ID: J2335657-SGA

  • Ubicación
    Bettlach, Soleura, Switzerland
    Grenchen, Soleura, Switzerland
  • Categoría Riesgos y Garantias
  • Publicado miércoles, 14 de septiembre de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

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

JOB SUMMARY

Overall responsibilities

The Regulatory Compliance Site Lead supports effective implementation of the business wide compliance program that meets requirements for the medical device business. This position partners with other Regulatory Compliance leaders to ensure audit readiness and overall compliance through internal audit process and supplier audit process. Regulatory Compliance Site Lead collaborates with different partners to further refine short- and long-term compliance objectives. This role provides Quality System Compliance support to the assigned site(s).

This includes the procedures and records required for the development, deployment, and maintenance of quality system processes to assure the ongoing compliance with MDSAP, ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.

Position duties and responsibilities

  • Responsible for ensuring compliance with all local, national, international and company regulations, policies, and procedures
  • Conducts and leads Internal Audit as per Internal Audit schedule
  • Conducts and leads Supplier Audits as per Supplier Audit schedule
  • Supports Compliance improvements, which result from audits, Quality Board Issues and other system indicators
  • Seeks opportunities to work with the other site compliance specialists to ensure consistent systems across the organization
  • As Jabil Regulatory & Compliance representative, in close collaboration with site management, coordinates on a continuous basis, Inspection Readiness to prepare the site for external audit announced or unannounced.
  • Supports proper internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools
  • Trains and maintains users on the Audit system “EtQ” - Act as site system Audit module support
  • Provides Front Room/ Back Room support during external audits
  • Establishes and maintains regulatory inspection readiness plans for assigned sites
  • Supports external audits and assessments that take place on Jabil sites and serves as the Subject Matter Expert for the Internal Audit process and Supplier Audit process
  • If necessary, assists other facilities during external audit preparation and external audit execution
  • Performs 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

Education Requirements:

  • At least Bachelor’s degree in Science, Engineering, Quality or another technical field
  • Equivalent degree and/or adequate associated work experience is acceptable
  • Lead Auditor qualifications are recommended

Further Education :

  • Knowledge of Quality Systems (21 CFR 820/ISO 13485/ISO 9001) within a regulated environment

Experience:

  • At least 4 to 6 years working experience in a regulated industry
  • At least 1-year experience in a quality and/or compliance function
  • Experience in performing audits is recommended

Interpersonal skills / characteristics :

  • High Attention to Detail
  • Ability to make complex issues simple
  • Excellent Communication Skills (written & oral)
  • Team Player
  • Excellent time management
  • Focus on achievement and delivery of results
  • Active Listener

Other requirements :

  • Available to travel
  • Fluent Business English

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.

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