Quality Systems Analyst

e doing:

• RIM management: document archiving and electronic recording

• CAPA/NC responsibility and tracking of relevant activities in ETQ, creating reports

• Document management system: creating and changing process descriptions, creating change requests, periodic reviews

• Audits: Organizing and accompanying internal and external audits, tracking follow-up measures and documenting them

• Processing deviations and supporting team members

• Gemba Walks & Audit Readiness: Regular production walks in preparation for audits, tracking of follow-up measures and their documentation

• QPR/QSMR: Preparation of management reports per quarter and half-year

Qualifications

We would love to hear from YOU if you have the following essential requirements:

EXPERIENCE AND EDUCATION

• University/Bachelor's Degree or equivalent experience and supporting education (e.g., Technical Qualification with Further Education)

• Minimum of two (2) years of experience or equivalent combination of education and experience is required. Related experience in Medical Device or Pharmaceutical environment is preferred.

• Advanced use of computer and software applications is required, particularly Microsoft PowerPoint, Excel, Word, SharePoint, Outlook, and Teams.

• Experience with training or coaching others is required.

• Experience in working in a manufacturing/operations environment is preferred.

• Knowledge of ISO standards or QS regulations is preferred.

• Experience in notified body and/or health authority audits is preferred.

• Experience with root cause investigation, technical writing, change management, and/or risk management is preferred.

• Experience in Quality Systems process development or enhancement is preferred.

• Experience in project management is preferred.

• A certification in process excellence is preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Strong verbal and written communication, influencing, and leadership skills; ability to communicate at all levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results is required.

• Strong interpersonal skills with diverse cultures and business practices is required.

• Strong verbal and written communications skills for multi-level stakeholders

• Strategic and tactical execution abilities, including strong organization skills is required.

• Ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required.

• Ability to apply principles of logical or scientific thinking, root cause and statistical analysis.

• Ability to analyze, graph, and present data in a way that facilitates and drives decision making.

• Strong verbal and written presentation skills.

• Must be detail-oriented and accurate.

• Must be time-oriented (i.e., able to recognize and adhere to strict timelines).

• English language skills are required. Proficiency in the German language is advantageous, but may be required depending on the location of the site.

What type of mark will YOU make?

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world's healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!

For more than 130 years, diversity, equity & inclusion 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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.