Job Posting Title Staff Quality Engineer

**Job Function**:
Quality
**Job Sub Function**:
Quality Systems
**Job Category**:
Professional
**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, Mexico, São José dos Campos, São Paulo, Brazil

**About MedTech**

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

United States and Puerto Rico
- Requisition Number: R-005177

**We are searching for the best talent for a Staff Quality Engineer - Escalations role.**

The Staff Quality Engineer is responsible for the end-to-end process related to product quality issue escalations through the decision-making framework of risk management and quality review boards to inform and support decisions to initiate field actions when appropriate.

**Key Responsibilities**:

- Execute and lead all associated activities related to the product risk escalation/assessment process to ensure compliance with internal and external requirements.
- Execute the overall escalation process from issue identification to presentation at the Risk Management Board (RMB) as well as the Quality Review Board (QRB), when required.
- Collect, create and review escalation documentation to ensure robustness and compliance.
- Prepare meeting content to the Risk Management Board and/or Quality Review Board to help facilitate the determinations of field actions and run the escalation meetings at the Risk Management Boards.
- Appropriately utilize risk management within the escalation process.
- Partner with Quality Operations, Compliance, Regulatory, R&D, Medical Safety, as well as other organizations who may own portions of a given product issue escalation.
- Provide periodic reports, presentations, and metrics related to product risk escalations to upper management as needed.
- Aspire to and effectively call peers to action and higher levels of accountability.
- Partner with and influence internal and external stakeholders to drive needed change and the execution of compliance related matters.
- Support data requests for audits, post market surveillance, regulatory registrations, etc, as well as provide data for periodic reports, presentations, and metrics related to product risk escalations.
- Implement/modify quality systems to address changing regulations or industry standard, providing regulatory interpretation and guidance where required.
- Support the growth of other team members, so the pipeline of J&J talent remains strong well into the future.
- Other responsibilities include but are not limited to: coordinate and participate in special projects as assigned; act as backup support for product escalation Quality Engineers or other product Field Action teams.
- Participate in various projects in the spirit of continuous improvement.
- Actively participate in audit and compliance review processes.
- Demonstrate customer support and maintaining knowledge of Ethicon products and services.
- Plan, coordinate and execute the onboarding training of new associates and/or existing associates.
- Identify, lead and/or support appropriate projects towards desired business outcomes.
- Promote a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace.
- Create a trusting, collaborative, and ethical work environment that positively contributes to employee engagement and retention.
- Support all needed Quality System and business related requests for data analysis, QSMR, BPDR, QRB, DRB, CAPA, NC, etc.

**Qualifications**

**Education**:

- A minimum of a Bachelor’s degree or equivalent in scientific and/or engineering discipline is required.

**Experience and Skills**
- Minimum of 6 years of related work experience is required.
- Experience in the medical device, pharmaceutical or other highly regulated industry preferred.
- Knowledge of ISO and/or cGMP regulations is preferred.
- Experience in an FDA regulated environment is an asset.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
- Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
- Able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Operations, Medical Affairs, Medical Safety, Compliance, Manufacturing, etc.
- Experience with internal/external audits, Risk Management, and recruiting/onboarding of prospective team members is preferred.
- Experience leading collaborative efforts within teams and implementing continuous improvement activities is preferred.
- Proven ability to successfully execute increased business responsibilities while maintaining high levels of productivity and quality of work.
- Excellent interpersonal relations, influencing and communication skills are required.
- Strong oral and written communications