Site Healthcare QMS / Compliance Lead (m/f/d)

Site Healthcare QMS / Compliance Lead (m/f/d)

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.

Job Description

Jabil is establishing a new manufacturing facility in Osijek, Croatia. This expansion is a strategic move that aligns with Jabil's focus on long-term secular trends and growth in renewable energy, electric vehicles, healthcare, 5G, and cloud. The new facility will serve as a hub for Jabil's continued commitment to innovation, sustainability, and delivering comprehensive manufacturing solutions to our customers and will employ over 1,500 people when fully operational.

If you’re ready to embrace unlimited possibilities and help world-class clients succeed, then you’ve come to the right place. Apply today for the position of Site Healthcare QMS/Compliance Lead (m/f/d) in Osijek, Croatia!

About the Company - Jabil has established a new manufacturing facility in Osijek, Croatia. This expansion is a strategic move that aligns with Jabil's focus on long-term secular trends and growth in electric vehicles and healthcare. The new facility serves as a hub for Jabil's continued commitment to innovation, sustainability, and delivering comprehensive manufacturing solutions to our customers.

About the Role - This position will have the responsibility and authority to lead the compliance and effectiveness of the Quality Management System as it applies to healthcare production. To assure that quality standards are maintained & to assist with NPI/changes to the QMS, to ensure that required standards/regulations are adhered to, and the most effective systems/approaches are used. To support in achieving company goals for the manufacture of medical devices through developing and maintaining standards to policies and procedures, quality systems, GMP regulations and ISO standards. Mentors functional management and key users of the Quality Management System to build understanding, compliance, and improvement of the QMS, in line with GMP and ISO regulations and standards.

Key Responsibilities:

• Lead, champion, and own site regulatory compliance for healthcare production.
• Preparation and hosting of any associated 2nd/3rd party audits.
• Manage the site GMP program, and healthcare related internal audits.
• Ownership and maintenance of the site healthcare QMS (in conjunction with QMS group).
• Manage key elements of the QMS, relating to healthcare production, including, but not limited to: Change Controls, Nonconforming Conformance Material Reports (NCMR’s), Deviations, CAPAs (Corrective Actions, Supplier Corrective Actions, Customer Complaints). Support Corporate initiatives in relation to changes, improvements, and alignment to Corporate QMS.
• Coordinate healthcare inputs to site Management Review.
• Develop a project management style plan for delivery of Healthcare QMS objectives across the year.
• Develop a score for QMS and quality management system compliance.
• Support the Behavioral Based Quality (BBQ) program.
• Deliver Healthcare QMS and GMP training at induction and routinely, as required (i.e. refresher).
• Lead new projects and lean/continuous improvement initiatives on the Healthcare QMS system.
• Stay informed of changes and best practices in the medical device industry and communicate to the site.
• Work collaboratively and supportively with all departments on site to support high standards of documentation and report writing.
• Coaching and mentoring SLT, Functional Managers, and SMEs on site to increase GMP knowledge and compliance.
• Ensure ongoing compliance with GMP/GDP standards and ISO 13485 standards.
• Develop a data integrity program.
• Develop a quality risk profile for all potential and prospective quality risks on site.
• Support all company safety and quality programs and initiatives.
• Ensure ongoing compliance with GMP in all practices, recording of events and processes.
• Ensure compliance with all learnings from all GMP training events.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

Qualifications:

• Minimum 5 years’ experience in a Quality Leadership role or similar.
• Knowledge of cGMP and ISO13485 is essential.
• Experience with Regulatory / Customer Audits is essential.
• Degree qualified in a related science.

Skills and Attributes:

• Willingness to travel (possible on-boarding training in the United States).
• Excellent Leadership skills, ability to motivate team members within the organization. (Energetic & enthusiastic individual).
• A collaborative individual who will work with their peers to deliver site QMS targets and develop further the quality culture at Jabil Healthcare Osijek.
• Ability to clearly communicate regulatory requirements, and help peers translate them into robust systems, processes, and required day to day behaviors.
• Excellent organization, communication, computer & presentation skills.
• Excellent initiative, decision making and be able to work in a core team environment and on their own initiative.
• Solution driven with emphasis on performance and results.
• Individual with an experienced background in manufacturing within controlled / GMP environment.

What we can offer you:

• Annual metric based bonus.
• Two additional paid vacation days.
• One additional paid vacation day for volunteers.
• Fringe bonuses.
• Additional health insurance.

If you are interested, please apply online with your CV in English.

To learn more about Osijek and its qualities click HERE and HERE.

Virtual Tour of Osijek

If you are interested, please apply online with your CV in 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.

Accessibility Accommodation

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 from this e-mail address.

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