Quality Process Lead

vor 1 Woche

Zuchwil, Schweiz Johnson & Johnson Vollzeit

**"Caring for the worldone person at a time”**inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable **Credo**

**Quality Process Lead**

**Overall responsibilities**
- Project Management for Stop Shipments
- Project Management for Batch Management
- Provide product traceability

**Position duties and responsibilities**
- Responsible for the overall and compliant execution of global Stop Shipments
- Coordinating, leading communication between stakeholders, LOCs and management
- Provide ERP support and guidance
- Restricting and unrestricting products in SAP and JDE
- Ensuring proper storage for products which are related to Quality Holds and Field Actions, and

follow applicable regulatory guidelines
- Provide product traceability with support of the LOCs / ERP for escalations and Field Actions
- Create and execute reports and statistics
- Responsible for the overall and compliant execution of Batch Management requests
- Changing, creating and maintaining critical batch information (e.g. Expiry Date..)
- Analyze, define and revise procedures, work instructions and documentations
- Assess process opportunities
- Implement Process Improvements
- Define, create and execute training / e-learnings
- Provide quality systems guidance, own and support the Non-Conformance, Complaint Handling and Corrective and Preventive Action (CAPA) process
- Work with stakeholders to ensure NC (Non-Conformance) compliance
- Providing support for investigations related to quality issues
- Ensuring proper storage and maintenance of quality records
- Monitor, anlayze, and report Quality Systems metrics to management
- Supports Compliance activities by participating in internal and external audit preparations and serving as Subject Matter Expert during these audits
- Lead projects
- Manage and execute team marketing activities (such as but not limited to Yammer, Sharepoint etc.)

**Extended duties**
- Collaboration and participation in cross-functional projects
- Perform translation and translation verifications
- Identify and recommend business needs
- Provide support and guidance for escalations and Field Action
- SAP Key User for US (for access to system and transactions)
- Support the Supply Chain product flow

**Qualifications**

**Qualifications & Experience**

Educational requirements:

- Completed apprenticeship and multiple years of job experience in Quality environment

or
- Higher school education (e.g. Federal Vocational Baccalaureate) with multiple years of job experience

Further Education:

- Familiar with ISO and FDA standards for medical prodcuts (ISO 13485 and 21CFR820)
- Project Management certificate or equivalent experience (IPMA, FPX, SixSigma etc.)

**Experience**:

- Multiple years of experience in a Quality environment / Quality Analyst
- A very good understanding of the Microsoft office tools such as Outlook, Excel, Powerpoint, Visio and Office365
- Analyzing and writing procedures (German and English)
- Process Improvements
- ERP systems, preferable SAP and/or JDE
- Diverse work environment
- International work environment (optional)
- Healthcare/medical device environment (optional)
- Adobe Lifecycle (optional)

Interpersonal skills / characteristics:

- Very good communication skills in German and English (verbal and written)
- High degree of responsibility
- Team player
- Ability to work cross functional and with diverse teams
- Able to work independently
- Customer focused
- Solution oriented
- Attention to detail
- Reliability
- Structured in order to meet deadlines consistently
- Technical affinity
- Flexibility and willingness to learn
- Open-minded (outside of the box thinker)
- Ability to handle conflicts

Minimum Language required:

- German business fluent
- English business fluent

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

**Primary Location**
Switzerland-Solothurn-Zuchwil-**Organization**
Synthes GmbH (7111)

**Job Function**
Quality

**Requisition ID**
2206067078W

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