Senior Maintenance Quality Engineer

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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

A Senior Maintenance Quality Engineer is an experienced professional responsible for leading quality assurance efforts within the maintenance organization to ensure products, processes, and systems meet or exceed customer expectations, regulatory requirements, and industry standards.

They play a vital role in driving continuous improvement initiatives, managing complex quality challenges, and mentoring junior team members. Acting as a
technical expert and quality leader, they focus on enhancing product reliability, minimizing defects, and optimizing processes to achieve operational excellence:

General responsibilities:

• Perform related duties as assigned by supervisor/manager.
• Maintain compliance with all company policies and procedures.
• Initiate, drive and lead cross-functional Maintenance quality improvements in close
• collaboration with stakeholders. Includes support conduct formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.
• Work with cross-functional teams to analyze and solve problems (i.e. Operations, QC, QA).
• Communicate and escalate in a timely manner, any Quality Engineering issues, or concerns to the next management level.
• Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• High degree of accuracy and a quality attitude.
• Delivers effective support in core area to multiple projects or programs. Gains progressive experience. Proposes new improvements in processes and/or methodologies
• Must be able to work independently with minimum supervision to meet tight deadlines while fostering a positive attitude.
  

Change Control

• Initiate, implement and assist the MAM organization with medium/high risk Change
• Controls through expertise and administrative actions.
  

Non-Conformances

• Apply expertise of Quality requirements (e.g. Lead Non-Conformances and root cause investigations, including CAPA records). Identify, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Organize and chair ETM meetings.
• Perform HFACs interviews, reporting and the follow-ups.
• Highly experienced with formal problem-solving methodologies and deductive skills.
• Able to lead medium to high impact root cause investigation analysis sessions with no supervision (i.e. Event map, IS ISNOT, etc.).
  

Maintenance Quality Assessments

• Oversee and provide support in assessing SAP notifications, obtain the correct information from the various disciplines, when found necessary, and act as a first point of contact for QA related questions.
• Maintenance documentation review after execution of preventive and corrective maintenance.
• Process N6 SAP notifications regarding the creation and modification of Preventive Maintenance, Periodic Evaluation, and Periodic Review Plans”.
• Final inspection of TECO SAP orders after execution of preventive and corrective maintenance
  

Documentation management

• Coordinate the document creation and update request with the in the team and support were needed (which might include practical tasks).Coordinate the document routing for new or existing documents (i.e. SOP, WI etc.)
• Coordinate the periodic reviews of curriculum content and the correct linking of people to the correct curricula.

Audits/Inspections

• Actively support the internal and external audits/inspections.
  

Minimum Qualification

• Master’s degree in engineering, Life Sciences or relevant subjects or bachelor’s degree in engineering, life Sciences or related subjects with 3 – 7 years working in work experience in pharmaceutical or equivalent industry.

• Excellent verbal and written communication skills in English, including ability to effectively communicate with internal and external customers on professional level up to departmental management.
• Highly experienced with formal problem-solving methodologies and deductive skills.
• Excellent computer proficiency e.g. MS Office, SAP, Quality System, Document Management System, Training System.
  

Other Requirements

• • Is able to present and defend departmental quality assurance practices and findings to senior management (e.g. SLT, ECB, CCB).
• Strong analytical thinking: ability and dealing with complexity, asking questions, using data, using information, and identifying gaps and root causes of issues, and be innovative (be able to think creatively) to develop a solution.

The anticipated base pay range for this position is 52,500 to 84.180 on an annual basis and includes 8% holiday allowance.

#LI-MV2
#Hybrid

#LI-MV2
#Hybrid