Product Quality Vigilance, Quality Engineer

Biopharma Careers; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson Beerse is seeking a Senior Quality Engineer within Supply Chain Engineering to lead PQC investigations for Innovative Medicine products and collaborate across sites to ensure readiness and compliance.

The role emphasizes data-driven decision making, cross-functional partnership with R&D, and leadership in quality vigilance projects, while ensuring adherence to QSR requirements and regulatory standards.

Qualifications

• 5+ years of experience including Quality Assurance and/or Quality Control in Pharmaceutical and/or Medical Device industries.
• Knowledge of medical safety environment and regulation.
• 2.5+ years of experience in Complaint Management, Post‑Market Vigilance, Risk Management or Compliance preferred.
• Supervisory experience desirable.
• Global mindset and demonstrated ability for change initiatives, project management, and develop strong working relationships; knowledge of regulatory requirements.
• BA/BS in technical, scientific or engineering disciplines required; MA/MS/MBA desirable.

Responsabilités

• Lead, conduct, and support investigation of Innovative Medicine Product Quality Complaints (PQCs) for commercial and clinical products with site collaboration.
• Coordinate information from a technical perspective to ensure analyses and failure modes are documented before closure.
• Lead Product Quality Vigilance projects and new business initiatives ensuring transfer of knowledge.
• Collaborate across departments/sites with R&D and NPI teams for product readiness and PQV support.
• Act as Site PQV consultant for investigations and surveillance activities.
• Support qualification and audit processes and assist in submission of Medical Device Reports.
• Serve as Single Point of Contact (SPOC) for PQV at Manufacturing Sites; back up other SPOCs as needed.
• Drive continuous improvement, statistical/data-driven decision making and risk management processes.

Connaissances

Quality Assurance

Quality Control

Regulatory knowledge

Project management

Strong communication

Six Sigma

CQE (ASQ)

Global mindset

Change management

Formation

BA/BS in technical, scientific or engineering disciplines

MA/MS/MBA in technical, scientific or engineering disciplines desirable

Description du poste

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium, Turnhout, Antwerp, Belgium

Job Description:

Essential Job Duties and Responsibilities

• Lead, conduct, and support investigation of Innovative Medicine Product Quality Complaints (PQCs) for commercial and clinical products in close cooperation with the manufacturing sites, ensuring documentation in the PQC database.
• Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failure modes are executed and documented prior to complaint closure.
• Lead Product Quality Vigilance projects and new business projects to ensure complaint and effective data/knowledge transfer.
• Collaborate across departments and sites, acting as liaison with R&D and New Product Introduction teams to ensure new products readiness for complaint vigilance quality process support and other functions.
• Act as a Site PQV consultant for investigations.
• Lead, conduct, and support holistic complaint investigations for Innovative Medicine Drug Products.
• Coordinate and support failure investigations and assist in the processes for submission of Medical Device Reports.
• Act as Single Point of Contact (SPOC) of PQV for Manufacturing Sites.
• Back up other SPOCs (cross‑train on other site products and processes).
• Partner with Site to raise awareness of aging/coming due/prioritization.
• Involved with complaint‑related site escalations to ensure any impact to future complaints is identified.
• Communicate site issues and opportunities to the E2E Team.
• Execute statistical and data‑driven processes and documentation to support controlled risk management and decision making, ensuring appropriate statistical/data‑driven decision making is incorporated into processes.
• Participate in signal trend evaluations relating to site products.
• Partner with customers (Manufacturing Sites, PDMs, Contact Center, Global Medical Safety, Marketing, Sales Administration, Brand Protection, EQ, PQM, etc.) to gain knowledge of products and processes.
• Improve existing methods and processes for conducting product investigations.
• Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failure modes have been analyzed and documented prior to complaint closure.
• Execute transactional tasks to support complaint management processes, including data collection, correction and upload.
• Support internal and external audits and inspections.
• Lead projects for Product Quality Vigilance, collaborating across departments and sites.
• Actively manage consumer relationships (with manufacturing sites, LOCs, Product Quality Management, GMS, JJQS, IT, etc.).
• Provide guidance and expertise to internal and external partners for the interpretation, implementation, and execution of QSR requirements related to product complaint investigation.
• Drive technical and process improvement and influence change.
• Solicit customer feedback.
• Educate, train and support on product and process knowledge relevant to site responsibility (E2E).
• Create and maintain work instructions and standard operating procedures relative to root cause investigation for complaint management processes.
• Develop and deliver training for colleagues and partners on the complaint investigation process and product‑specific information.
• Support the technical writing and provide analytical support in correct investigation outcome interpretation to answer Health Authority Requests related to complaint handling.

Minimum Qualification

• 5+ years of experience including Quality Assurance and/or Quality Control, including experience in Pharmaceutical and/or Medical Device or other related highly regulated industry.
• Knowledge of medical safety environment and regulation.
• 5+ years of related experience in Medical Device or Pharmaceutical industry required.
• 2.5+ years of experience in Complaint Management, Post‑Market Vigilance, Risk Management or Compliance preferred.
• Supervisory experience desirable.
• Global mindset and demonstrated ability for change initiatives, project management, and develop strong working relationships, knowledge of and experience with regulatory requirements.
• Ability to communicate effectively verbally and in writing (technical and persuasive).
• Ability to present to multiple levels and departments within the organization.
• BA/BS in technical, scientific or engineering disciplines required.
• MA/MS/MBA in technical, scientific or engineering disciplines desirable.
• Green Belt (Six Sigma) desirable or other investigation training required.
• Black Belt (Six Sigma) CQE (ASQ) certification preferred.

Preferred Skills

• Coaching
• Consistency
• Controls Compliance
• Critical Thinking
• Data Savvy
• Engineering
• Financial Competence
• Good Automated Manufacturing Practice (GAMP)
• ISO 9001
• Lean Supply Chain Management
• Leverages Information
• Process Improvements
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Quality Validation
• Science
• Technology
• Engineering
• and Math (STEM) Application
• Technologically Savvy

The anticipated base pay range for this position is: €72,500.00 - €115,230.00

Benefits

• 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.
• 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
• Service anniversary and recognition awards
• Several insurance plans (subject to the terms of their respective plans, employees and in some locations’ eligible dependents can participate)

For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.