Wien, Austria
About Surgery
Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer.
Role Overview
Under the general direction of the Lead Commercial Quality Surgery Austria/Israel/Switzerland cluster, this position is responsible for establishing and leading Johnson & Johnson overall quality management framework and quality system for Surgery business in Austria, establishing preventive and corrective actions to mitigate potential or actual non‑compliance risks and ensuring compliance to attain world‑class operational/customer focused capabilities. The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals. The lead is responsible to lead activities towards the integration of the quality management systems for Surgery in Austria. This position is responsible for ensuring the QMS requirements are effectively executed in the country in accordance with local regulations, corporate and segment policies and procedures. The role will interface with related organizations to ensure a consistent and systematic process is followed and that metrics are reported timely.
Responsibilities and Impact
* Serve as an SME for the assigned Quality System processes e.g. Document & Record Management, Quality Agreements, Change Control, Audit & Inspection, Repack Relabel, Purchasing Controls, CAPA, etc.
* Provide guidance and support and coaching on assigned processes & systems.
* Ensure adequate communication of quality compliance needs and status to all affected sites/organizations.
* Drive simplification, standardization and continuous improvement of processes across the EMEA region.
* Ensure timely and consistent reporting of metrics and KPIs associated with assigned processes.
* Provide regional audit/inspection readiness support.
* Build strategic partnerships regionally and globally, and support development of solutions and ensure implementation with region.
* Conduct supplier, distributor and 3PL audits; track follow‑up activities to address observations after the audits.
* Manage product quality complaints and adverse events process in liaison with franchise quality team, local commercial team, distributors and brand protection.
* Ensure compliant and timely field action execution.
* Drive complaint vigilance execution in the countries, where applicable, ensuring the timely closure of product related complaints cases, quality, and immediate escalation.
* Understand current requirements of Regulatory Agencies such as local MOHs and standard organizations such as ISO.
* Monitor compliance with company policies and J&J quality procedures.
* Evaluate quality processes and recommend improvements to meet regulatory requirements.
* Ensure compliance with country applicable regulation.
* Monitor trends, identify issues, recommend and implement appropriate actions, and assist in the development, implementation and review of standard operating procedures.
* Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.
* Perform other related duties as required.
Qualifications & Requirements
* Excellent spoken and written German and English.
* Located in Austria, preferably Vienna.
* Bachelor’s degree in engineering, scientific, business or QRC disciplines. Equivalent relevant industry experience accepted in place of a degree.
* +5 years experience in regulated industries (medical device, pharma, consumer).
* Compliance experience, QMS experience.
* Change management and project management experience.
* Strong presentation skills.
* Collaborative approach, team player.
* Managing complexity, working in a matrix organization.
* Detailed understanding of QM Systems and local/regional (EMEA) medical device regulations.
* Experience with ISO certification, notified body; health authority inspection experience.
* Understanding linkages in quality and regulatory compliance for customer and health authority delivery.
* Strong analytical and risk‑based problem‑solving skills.
* Well organized, with strong communication skills.
* Strong collaboration and influence management skills to partner effectively across functions and operating units.
* Hands‑on approach.
* Ability to fit in well culturally in a complex organization.
* Demonstrated understanding of AI concepts and frameworks, including responsible and ethical AI practices, and experience generating effective prompts to boost efficiency and productivity.
Preferred Skills
Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP).
Compensation
Anticipated base pay range: €69,000.00 – €109,480.00.
Benefits
* Annual bonus with set target (% of pay) depending on pay grade / location, based on employee and company performance.
* Vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health.
* Service anniversary and recognition awards.
* Eligible dependents may participate in several insurance plans as per plan terms.
* Other benefits vary by location and are subject to change.
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