Product Quality Vigilance, Quality Engineer

Essential Job Duties and Responsibilities

PQV Quality Engineer 4 will be responsible to lead, conduct and support investigation of Innovative Medicine Product Quality Complaints (PQCs) for commercial and clinical products in close cooperation with the manufacturing sites, and to ensure a complete holistic: Investigation for PQCs is documented in PQC database. Evaluates information from technical perspective to ensure appropriate analysis, investigation and failure modes have been executed and documented prior complaint closure.

Leads Product Quality Vigilance projects and new business projects to ensure complaint and effective data/ knowledge transfer. Collaborates across departments and sites and be the liaison with R&D and New Product Introduction team to ensure new products readiness for complaint vigilance quality process support and other functions.

• Site PQV consultant for investigations.

• Lead, conduct and support holistic complaint investigations support 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 (aware all escalation to see if any impact to future complaints).

• Communication of sites issues and opportunities to E2E Team.

• Execute 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 Center (LOCs), 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 failures modes have been analyzed and documented prior to complaint closure.

• Execute transactional tasks to support complaint management process (data collection/correction/ upload, etc.)

• Support internal and external audits and inspections.

• Lead project for Product Quality Vigilance, collaborate across departments and sites.

• Actively manage consumer relationships (with manufacturing sites, LOC´s, 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 /Support on Product and Process knowledge relate to site responsible (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 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.

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 department 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.