Posted: 16 June
The role
PQVIS Quality Engineer
Location: Cork
Duration: 12 Months
Hours: 39 hours
The Quality Engineer is responsible to 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 that a complete holistic investigation for PQCs is documented in the PQC database. They evaluate information from a technical and quality perspective to ensure appropriate analysis, investigation and failure modes have been executed and documented prior to complaint closure. The Quality Engineer provides guidance to investigational groups in conducting holistic investigations and appropriate root cause investigations and provides adequate training and tools. Acts as a single point of contact (SPOC) of PQV for the manufacturing sites and partners with the sites to raise awareness of aging/coming due/prioritization. The Quality Engineer supports and coordinates Failure Investigations and assists in the processes for submission of Medical Device Reports. They manage appropriate Corrective/Preventive actions related to Complaint Investigations, ensure on time escalation as per Escalation Standard/SOP and support Regulatory and Field Actions Committees and Health Authority Inspections. Also supports projects for Product Quality Vigilance, collaborates across departments and sites and provides product or regional customer insights to reporting/surveillance team and other business partners to improve design inputs and assist in the processes for submission of Medical Device Reports based on expected reporting requirements.
Travel Requirements: This position may require up to 5-10% travel domestically and internationally. Environmental Requirements: It is required for the incumbent to follow all safety procedures to minimize health hazards. Physical/Work Requirements: Working at a computer for extended periods of time. Working independently in a global team.
Roles and Responsibilities
Complaint Management Investigations
Site PQV consultant for investigations.
Conduct and support holistic complaint investigation support for Janssen commercial and clinical Products PQCs.
Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failure modes have been analyzed and documented prior to complaint closure.
Review and monitor complaint investigation practices across different departments to ensure standard process is followed, data consistency and high data quality for correct decision making.
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.
Utilize effective and efficient Quality Engineering / Process Excellence techniques.
Coordinate and support Failure Investigations and assist in the processes for submission of Medical Device Reports.
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.
Identify gaps, redundancies and inaccuracies to improve the complaint investigation process.
Support internal and external audits and inspections.
Business Relations
Actively manage customer relationships (with JJQS, LOCs, Manufacturing Sites, PDMS, GMS, EQ, Product Quality Management, IT, Business Partners, etc.)
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 related to root cause investigation for complaint management processes.
Develop and deliver training for colleagues, investigational sites and other partners on 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.
How to Succeed
3-5 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.
3+ years of related experience in Medical Device or Pharmaceutical industry required.
1-3+ 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 13485:2003, 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.
Benefits
This role offers a very competitive hourly rate. This contract will run for 12 months.
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