Business Quality Manager, CEE Central Region
The Medical Devices sector of Johnson & Johnson produces a broad range of innovative products used primarily by health care professionals in the fields of orthopedics, neurovascular, surgery, infection prevention, cardiovascular disease, sports medicine, and aesthetics.
We are providing our clients with the most innovative and comprehensive orthopedic and neurological portfolio in the world, offering inspired solutions that go beyond quality implants and include services, education, instruments, and emerging technologies. Through the Medical Devices we deliver innovation to make a life-changing impact.
As a Business Quality Manager, you will be responsible for overall Business Quality Leadership in Medical Devices Marketing Company in CEE Central Region (CZ/SK/HU).
You will have the following areas of responsibility:
- Ensure compliance to all applicable quality standards & regulatory requirements, coordinating the timely and effective deployment of J&J Standards requirements;
- Drive simplification & standardization of Quality System in line with J&J/MD strategies & initiatives;
- Establish corrective action & preventive actions to mitigate potential or actual non-compliance risk;
- Embed Quality Management System management principles in the country’s organization & drive continuous improvement;
- Develop, lead and maintain a comprehensive audit readiness program to ensure internal and external quality compliance;
- Ensure timely and consistent escalation of events;
- Ensure timely post market surveillance & vigilance (Field Actions and Product Complaints) management;
- Maintain training program with respect to Quality System elements;
- Connect with the business and functional leaders through active participation in their Management Meetings and Commercial Boards as applicable;
- Maintain knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs;
- Establish local and regional relationships with regulatory affairs, business partners and internal/external quality regulatory compliance groups;
- Control and manage BQ head-count in CEE Central Region;
- Act as a Management Representative (Quality System Management Reviews) for CEE Central Region;
- Maintain quality oversight to supplier and distributor management process (assessment, qualification, monitoring)
Knowledge, Skills, Competencies and Experience
- Bachelors or Master’s degree in Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality leadership roles
- 5+ years working experience in the Medical Device Industry
- 5+ years working experience in quality function
- Recommended experience of Process Excellence
- Audit Management experience (Health Authorities, Notified Bodies)
- Recommended experience of supplier audit
- Track record of developing people, leading or coaching teams and driving results
- Change management experience and influencing and interpersonal skills
- Experience working in a global or regional context would be desired
- Excellent written and oral English communication skills are required
- Ability to effectively present information to management and public groups is required
- A challenging and interesting job in one of the biggest global healthcare companies
- An opportunity to make an impact with your actions
- Possibilities for own further development and growth
- Many opportunities to participate in different projects and drive our growth further
- Motivating remuneration and annual bonus
How to apply:
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your structured professional CV and short cover letter in English through the "Apply for the position" button below. You will be redirected to our career page and guided through the application. Should you face any technical issues, please contact us on career(at)its.jnj.com.
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