Process Quality Engineer (mwd), 1 year fixed-term

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About MedTech

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

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Process Quality Engineer (m/w/d) to be in Norderstedt.

This position is a fixed-term contract with a duration of one year.

Purpose:

The Process Quality Engineer provides technical knowledge towards the identification of the causes for non-conformances and process failures and for the implementation of the immediate corrective and preventive actions thus compliance with all applicable regulatory requirements and company policies for the entire Business Unit manufacturing process.

You will be responsible for:

• Reviewing quality trends analyzing data and recommending process equipment and system improvements.

• Guiding manufacturing teams and supervisors to ensure thorough investigations and effective corrective/preventive actions (CAPA).

• Leading cross-functional technical teams to identify root causes of nonconformances and drive sustainable solutions.

• Using process/documentation KPIs to identify improvement opportunities and support performanceenhancing initiatives.

• Evaluating the effectiveness of implemented CAPAs and recommending further actions where needed.

• Managing qualityrelated projects (e.g. CAPA lead internal observations) including coordination of internal and external resources.

• Ensuring compliance with J&J quality procedures Six Sigma principles and change management standards.

• Supporting safety practices ensuring regulatory compliance communicating businessrelevant issues and performing additional duties as assigned.

Qualifications / Requirements:

• As a minimum Bachelors degree (Engineering or equivalent in a Life Science Engineering or Physical Science field). Masters degree preferred.

• Thorough knowledge in QSR GMP ISO knowledge in applied statistics and failure mode analysis techniques. Experience in the QSR/ISO-regulated medical device operations preferred.

• Strong analytical thinking communication skills and ability to explain complex technical topics clearly.

• Six Sigma and/or Lean education and/or other sound statistical knowledge.

• Proficiency in preparing technical reports and presentations.

• Good MS Office skills and familiarity with technical standards and legal requirements.

• Fluency in German and English both spoken with strong ability to simplify complex content.

• Capable of prudent risk assessment and decisionmaking.

The anticipated base pay range for this position is 51200 EUR to 80845 EUR/gross per year.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.

• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

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