At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 250,000 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.
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At Jabil, we strive to make EVERYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees in 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted provider of manufacturing solutions. 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 the success of the world's leading brands. Our shared goal is to positively impact each other, our communities and the environment.
Our Regulatory Compliance team is looking for a
Senior Regulatory Compliance Site Lead (Internal Auditor) (m/f/d) 100%
to join them as of immediately or by arrangement.
Location: Tuttlingen (Germany)
The Sr. 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. 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 ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.
Your tasks 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
- Supports Compliance improvements, which result from audits, Quality Board Issues and other system indicators
- Seeks opportunities to work with the other site compliance site leads 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
- Provides Front Room/ Back Room support during external audits
- Establishes and maintains regulatory inspection readiness plans
- Supports external audits and assessments that take place on Jabil sites and serves as the Subject Matter Expert for the Internal Audit process
- If necessary, assists other facilities during external audit preparation and external audit execution
- This role does not include people management
- Bachelor’s degree in Science, Engineering, Quality or another technical field, or equivalent degree and/or adequate associated work experience
- A minimum of 6-8 years related work experience to include progressively more responsible duties relating to audit, projects and global initiatives
- ISO13485 Lead Auditor qualification as well as experience in auditing is a strong benefit
- Knowledge of Quality Systems (21 CFR 820/ISO 13485/ISO 9001) within a regulated environment
- High attention to details, the ability to make complex issues simple as well as the focus on achievement and delivery of results is needed
- We are looking for a team player with excellent communication skills (written & oral)
- For sucessful auditing excellent time management as well as active listening skills are needed
- Availability to travel (~30%) to different sites
- Fluent English and German. Other languages are beneficial.
What we offer you:
- A responsible and varied job in a global company with a strong local presence
- Progressive employment conditions with long-term perspective
- A high level of personal responsibility and independent work
- A safe space for creative thinking and learning at the workplace
- Bonus system, extra vacation days and many other benefits
We are looking forward to receiving your complete application documents online! Say YES to Jabil and YES to a new challenge!
For further information, please contact Alexandra Voss (Senior Recruiter) at +41 79 529 99 86.
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.