Job Description:

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.

The Quality Engineer 4 will be responsible to lead, conduct and support the investigation of Janssen Product Quality Complaints for commercial and clinical products in close cooperation with the manufacturing sites and to ensure a complete holistic investigation for PQCs is documented in the PQC database. She/he evaluates information from a technical perspective to ensure appropriate analysis, investigation and failure modes have been executed and documented prior to complaint closure.

The Quality Engineer 4 provides coaching, training, and development of personnel, internally and externally to PQV, in documenting effective investigations and provide guidance and expertise to internal and external business partners for the interpretation, implementation, and execution of QSR requirements related to product complaint investigation. He/she acts as a single point of contact (SPOC) of PQV for the manufacturing sits and partners with the sites to raise awareness of aging/coming due/prioritization.

The Quality Engineer 4 supports and coordinates Failure Investigations, lead complex investigations within Product Quality Vigilance and assists in the processes for submission of Medical Device Report. He/she uses technical and product knowledge for accurate feedback for current product enhancements and future product development, and for escalation/awareness of issues and support Regulatory and will support Field Action Committees and Health Authority Inspections.

The Quality Engineer 4 also leads Product Quality Vigilance projects and new business projects to ensure compliant and effective data / knowledge transfer. He/she will collaborate across departments and sites and be the liaison with R&D and New Product Introduction teams to ensure new product readiness for complaint vigilance quality process support and other functions.

The Quality Engineer 4 participates directly or indirectly on Complaint Vigilance Review Board and project teams to develop, consolidate and/or improve complaint vigilance and related/interfacing processes and metrics. She/he will present complaint vigilance outcomes to senior management and interact with Device Experts/Product Quality Owners/Product Quality Integrators to recommend improvements and improve overall risk of the product.

Position duties & responsibilities:

COMPLAINT MANAGEMENT INVESTIGATIONS:

• Site PQV consultant for investigations.
• Lead, conduct and support holistic complaint investigation support for Janssen Combo and Drug Products PQCs.
• 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 (i.e. MDR).
• Involved with Complaint related site escalations (aware of all escalations to see if any impact to future complaints).
• Communication of site issues and process opportunities to E2E team.
• Executes statistical/data-driven processes and documentation to support controlled risk management and decision making. Ensures appropriate statistical/data-driven decision making is incorporated into processes.
• Participate in signal trend evaluations relate to site products (involvement)
• Partner with customers (Manufacturing Sites, PDMS, Contact Centers (LOC), Global Medical Safety, Marketing, PQM, Sales Administration, Brand Protection, EQ, 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 the complaint management process (Device History Record review and scanning, data collection/correction/upload, etc.).
• Lead projects for Product Quality Vigilance; collaborate across departments and sites.
• Support internal and external audits and inspections.

Business relations:

• Actively manage costumer relationships (with Manufacturing Sites, EQ, LOCs, Product Quality Management, GMS, JJQS, IT, etc).
• Provide guidance and expertise to internal and external business 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/Support on Product and Process knowledge relate to site responsible (E2E).

Documentation:

• Create and maintain WI´s and SOP´s relative root cause investigation for complaint management processes.
• Develop and deliver training for colleagues and partners on complaint investigation process, and product specific information.
• Supports the technical writing and provides analytical support in correct investigation outcome interpretation to answer Health Authority Requests related to Complaint Handling

Professional experience requirements:

• 5+ years of related experience including Quality Assurance and/or Quality Control, including experience working 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 relationships working knowledge of and experience with the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 13485:2016, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC
• Ability to communicate effectively verbally and in writing (technical and persuasive).
• Ability to present to multiple levels and departments within the organization.

Educational requirements:

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 formal investigation training required; Black Belt (Six Sigma) or CQE (ASQ) certification preferred.

Required Skills:

Preferred Skills: