Jabil has established a new manufacturing facility in Osijek, Croatia. The new facility serves as a hub for Jabil's continued commitment to innovation, sustainability, and delivering comprehensive manufacturing solutions to our customers. To find out more about Jabil in Osijek click HERE.
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 our position of The Healthcare Quality Lead Engineer in Osijek, Croatia!
Overview: The Healthcare Quality Lead Engineer is responsible for full ownership of Quality in the Healthcare business on-site. This includes Supplier Quality, QMS, Validation, Metrology, Incoming/In-Process QC, Batch Release, NPI, Quality Engineering, and other areas within the quality unit. The Quality Lead Engineer will serve as the Subject Matter Expert (SME) and primary contact for quality, representing the company to the highest standards.
Key Responsibilities:
- Lead and coordinate all quality activities related to healthcare quality, including Supplier Quality, QMS, Validation, Metrology, Incoming/In-process QC, Batch Release, NPI, and Quality Engineering.
- Act as the site SME for Healthcare Quality and Regulatory, providing coaching and mentoring to team members and functional leads to ensure compliance requirements are understood and implemented.
- Manage the development, modification, and maintenance of all quality evaluation and control systems in compliance with company policies, customer requirements, ISO13485, and government regulations (e.g., FDA 21CFR Part 820).
- Utilize influence to ensure compliance is maintained across all areas of interaction.
- Manage Quality/Compliance Key Performance Indicators and drive year-on-year improvements.
- Create a high-performing, flexible team that achieves excellent results through coaching, mentoring, and effective performance management.
- Ensure team members are trained in their roles and support the development of standard work, documentation, training, and work instruction activities.
- Exercise exceptional judgment regarding quality decisions to effectively serve quality, customer, and business needs.
- Approach quality proactively and recover quality matters quickly and effectively if issues arise.
- Manage and implement effective methods and procedures for inspecting, testing, and evaluating the precision and accuracy of raw materials, WIP, finished products, and production equipment.
- Manage statistical analysis projects to assess the cost and responsibility for products or materials that do not meet required standards and specifications.
- Ensure the Internal Audit program assesses the effectiveness of planned/implemented controls to meet customer and regulatory requirements, and that corrective actions drive effective fixes.
- Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with all company, customer, and regulatory requirements.
- Manage the development of sustainable, repeatable, and quantifiable business process improvements. Report to management on the status of quality assurance programs and practices.
- Understand risk management and establish high standards of risk management within the area.
- Manage quality agreements with suppliers, contractors, and customers as applicable.
- Coordinate critical business reviews with healthcare suppliers/customers as required.
- Support regional and/or corporate initiatives (e.g., Behaviour Based Quality (BBQ)).
- Lead the use of lean tools to drive continuous improvement within the Quality/Compliance function.
- Support all company safety and quality programs and initiatives.
- Perform other responsibilities as assigned based on the evolution of the company and department requirements.
Job Specifications:
- Degree in Science/Engineering or a relevant discipline (desirable).
- Management or relevant supervisory management qualification (desirable).
- 5+ years of supervisory/leadership experience in a senior quality role (essential).
- Qualifications and experience in Lean (Green Belt level) (desirable).
- Experience in management within a regulated healthcare environment (essential).
- Experience in medical device injection moulding and assembly operations (desirable).
Skills/Attributes:
- Excellent lean operations leadership, organizational, and communication skills.
- Customer-focused, motivated, enthusiastic, self-directed, and results-driven leader.
- Ability to motivate self and others and work effectively in a team environment.
- Excellent initiative and decision-making capabilities.
- High level of c-GMP, safe working practices, and awareness.
- Willingness to travel (possible on-boarding training in the United States).
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.
To learn more about Osijek and its attractions click HERE and HERE.
If you are interested, please apply online with your CV in English.
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.
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.
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.#whereyoubelong
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