Quality Engineering

vor 14 Stunden

Basel, 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.

We are looking for a passionate:
**Quality Engineer (fiexd-term contrat)**

**in Neuchâtel**

**Position overview**

The Quality Engineer II will utilize Quality Engineering tools and practices for the effective and efficient development, maintenance, optimization and sustaining of the global Non-Conformity process as priority. He or she will also utilize Quality Engineering and problem-solving skills to improve and maintain product/processes that are aligned with the overall Quality and Business. While supporting operation in Base Business production, he/she will use risk management tools to prevent unanticipated failure modes and improve capability of the different processes.

**Tasks & Responsibilities**:
Production/Process Controls
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretations as part of process improvements and day-to-day activities.
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Assess and interpret common versus special causes of variation in manufacturing processing.
- Support Operation when challenges happen in day-to-day production, participate/lead investigation and strategy to removes theses challenges while maintaining the highest quality standards of the products.
- Support and collaborate closely with Incoming Inspection department by providing technical expertise on components, finished products and their associated inspections.

Product Quality, Control & Disposition
- Supports activities related to the Material Review Board.
- Support/conduct investigation, bounding, documentation, review and approval of non-conformance and CAPA.Supports complaint analysis when needed.
- Escalation of quality issues as appropriate.
- Analyze/review/conduct action or effectiveness of CAPAs. Review root cause investigation according to an established process.
- Accountability of Quality Metrics.

Product/Process Qualification
- Approve/write, if needed, IQ, CSV, OQ, PQ, Test Method Validation, Validation Plans and Validation reports.

Risk Mitigation
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk and generate adverse effects to the process or to the patient.
- Support/lead risk implementation or update of risk management tool as (but not limited to) pFMEA.

Compliance / Regulatory
- Review/analyze whether current products and processes (including actions or decisions conducted) are in compliance to standards such as QSR, ISO 13485, MDR, MDSAP
- Champions compliance to applicable Global Regulations and standards, including support during internal or external audits.

**Qualifications** Experience**:

- A minimum of a bachelor’s degree, preferably in Engineering or related technical discipline, is required.
- A minimum of 2 years of experience in quality is required, ideally in a Medical Device company. 4 years minimum of experience in a Medical Device company would be an asset.
- Knowledge of Microsoft Pack Office and statistical software packages is preferred with the ability to preview, graph and analyze data and present data that would facilitate / drive decision making process.
- Good technical understanding of manufacturing equipment and processes would be a plus.
- Experience working in both an FDA and European regulatory environment is preferred.
- Working knowledge of GMPs, QSR, 21 CFR 820, MDD, MDR, ISO13485 and ISO14971 is preferred.
- Working knowledge of CSV would be a plus.
- Process Excellence (6 Sigma or Lean) training required, certification would be a plus.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Knowledge and experience in reading technical drawings and associated measurement, including GD&T standard, would be an asset.

**Interpersonal skills / characteristics**:

- Ability to “think out of the box”, flexibility, open-minded, team spirit and “can do” attitude are required personal skills.
- Good technical understanding of manufacturing processes is required, ideally with human-based manufacturing processes.
- Ability to challenge the status quo.
- Proven evidences of multi-tasking and proven evidences of taking ownership of action are required.
- Excellent problem solving, decision-making based on risk evaluation

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