PQVIS Quality Engineer

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. 

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.