At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.
Job Description
Jabil Healthcare is the world's largest healthcare design and manufacturing services company, helping to improve the health and well-being of people around the world. Become a part of it and contribute to the development, design and manufacturing of products and solutions on behalf of leading international healthcare brands to improve patient health.
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Our compliance team in Bettlach und Grenchen, is looking for a
Senior Regulatory Compliance Site Lead (Internal Auditor) (m/f/d) 100%
to join them as of immediately or by arrangement.
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 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
- 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
- If necessary, assists other facilities during external audit preparation and external audit execution
- Note: This role does not include people management
Your background:
- Bachelor's degree in Science, Engineering, Quality or another technical field, or equivalent degree and/or adequate associated work experience
- A minimum of 6 years related work experience to include progressively more responsible duties relating to audit, projects and global initiatives
- ISO 13485 Lead Auditor qualifications as well as experience in auditing is recommended
- 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 in German and English, other languages (French) 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
- Home office possible (partially)
- 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!
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 identity, 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.
Accommodation Statement
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
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