Process Quality Lead (f/m/d)

Biopharma Careers; Norderstedt; Vor Ort; EUR 75.000 - 118.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Service awards

Zusammenfassung

Johnson & Johnson in Norderstedt, Germany is seeking a Process Engineering leader within Supply Chain Engineering to drive quality improvements and ensure compliance with QSR, GMP, and ISO standards across the Business Unit manufacturing process.

Under the Business Unit Manager, the successful candidate will lead investigations, guide cross‑functional teams, develop CAPA, and mentor staff while balancing shifts and global collaboration.

Qualifikationen

• Bachelor’s degree in Engineering or Science; Master’s degree preferred.
• Minimum six years’ work experience, with at least four years in QSR/ISO‑regulated medical device operation.
• Experience in a quality role within manufacturing preferred.

Aufgaben

• Reviews quality trends with manufacturing team and sets work priorities for process improvements.
• Guides manufacturing supervisors to ensure effective investigations.
• Leads cross‑functional teams to identify root causes and implement corrective/preventive actions.
• Leads investigations of negative trends and facilitates implementation of actions.
• Analyzes data and recommends process, equipment and system improvements.
• Writes procedures, protocols and documentation for process enhancement.
• Provides training on process evaluation tools (FMEA, analytical troubleshooting).
• Ensures compliance with QSR, GMP, ISO requirements and environmental, safety policies.

Kenntnisse

Bilingual English/German/Spanish

Analytical skills

Leadership

QSR/GMP/ISO knowledge

Statistical methods

Microsoft Office

Ausbildung

Bachelor’s degree in Engineering or Science

Master’s degree preferred

Tools

Microsoft Office

Jobbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Norderstedt, Schleswig-Holstein, Germany

Job Description:

Internal Job Posting 10.09.-24.09.2026

JOB SUMMARY*

Under the direction of the Business Unit Manager, provides technical leadership towards the identification of the causes for non-conformances and process’ failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.

Dedicated to develop, manufacture, and market quality products and to promote a quality Under the direction of the Business Unit Manager, the PQL provides technical leadership towards the identification of the causes for non-conformance and process' failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon's QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.

DUTIES & RESPONSIBILITIES

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
• Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.
• Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
• Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process.
• Analysis of data and based on the trends recommends actions for process, equipment and system improvement.
• Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems.
• Provides training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements).
• May lead a number of CAPA and should recommend CAPA’s based on negative trends.
• Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB.
• Leads in-process investigations with a multifunction team to determine root causes and provides recommendations for corrections on preventive actions.
• Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventive actions.
• Provides technical supervision to multilevel, cross functional teams. Provides supervision to technical professionals such as Process Quality Technicians, College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

Bachelor’s degree is required, Engineering or Science Degree preferred. Master’s Degree preferred.

Requires minimum of six 6 years work experience, with at least four (4) years of experience in the QSR/ISO required - regulated medical device operation preferred.

Experience in a quality role within the manufacturing industry preferred.

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

• Availability to various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.
• Bilingual (English & German/Spanish)
• Advanced computer skills (Microsoft Office) and use of software application(s) are required.
• Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.
• Proficient in the preparation of technical reports and presentations.
• Strong communication and interpersonal skills.
• Requires good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
• Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
• May requires working / visiting all three shifts of the operation and working irregular hours.
• Will require sitting for extended periods of time, writing reports on the computer.
• Some traveling may be required 10%.

Preferred Skills:

• Agile Decision Making, Developing Others, Efficiency Analysis, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Team Management, Technical Research, Technical Support, Vendor Selection

The anticipated base pay range for this position is:

€75.000,00 - €118.450,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.