Sr. Quality Scientist, Microbiology

Vor 7 Tagen

Aachen, Deutschland Johnson & Johnson Vollzeit

Principle Duties and Responsibilities:

- Facilitates the timely weekly BET, monthly Bioburden and annual re-certification process for EO sterilization processes globally.
- Works with R&D, manufacturing, and quality to bring new product and changes to existing products to completion as the sterilization SME.
- Works closely with engineering investigation teams to assure the timely closure of technical investigations.
- Coordinates monthly quarterly and annual environmental monitoring testing.
- Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals.
- Works with sterilization vendors in order to resolve ay non-conformances.
- Identify and implement improvements to the Environmental monitoring and sterilization systems.
- Prepare metrics and trending reports for Sr. Management monthly.
- Provide direction regarding Corrective and Preventative Actions that relate to the Product microbiology, sterilization and environmental monitoring.
- Interprets updates to applicable international standards and guidelines and implements them into the quality system.
- Assist management on departmental projects, as necessary.
- Other duties as specified.

**Qualifications**:

- Bachelor’s degree or equivalent required
- 5 years of related work experience desired; Medical device experience preferred
- Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus
- Excellent verbal and written communication skills
- Strong organizational skills; must be detailed-oriented
- Ability to execute tasks in a timely manner under general supervision
- Strong knowledge of Microsoft Office Suite and Adobe Acrobat

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

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