Job Description:
The Senior Specialist, Quality Systems will be a strong partner to the Client Diagnostics Global Quality and Regulatory function, as well as across the Client Information Solutions (RIS) Business Area.
Responsible for supporting development and implementation of the Quality Management System (QMS) and supporting infrastructure/tools in compliance with EU MDR, US FDA Quality System Regulation (QSR) regulations, ISO 13485, and Client corporate requirements within Q&R and cross functionally.
Supports administration of the Management Review process via establishment and reporting of Quality Management System requirements and metrics.
Provides project management leadership to various Quality-driven initiatives and represents Quality as-needed for representation in Company-wide improvement initiatives.
Actively participate in quality audits and regulatory inspection preparation efforts by supporting planning, gap analysis, and mitigation implementation activities required to comply with new regulations and standards.
Responsible for supporting generation of QMS documentation using the Electronic Document Management System (EDMS). Support coordination of document and record retention program for the site in alignment with the Client corporate requirements. Specifically, prepare and route for approval project-related documentation. This will involve managing many incoming documents and adhering to tight schedules. May involve (pre-approved) off hours or weekend support as milestone deadlines approach.
Support in identifying gaps in the modular Quality Management Systems procedures, performing gap assessments and assisting in driving compliance. Understanding of quality system procedures in the area of Digital Controls and cGMP requirements is a plus.
Experience in Change Management, Inspection and CAPA Management is an added advantage. Exposure to internal, external, supplier auditing programs as appropriate.
A proven ability to work creatively and analytically in a problem-solving and process-oriented environment. Expected to operate independently, holding accountable to proactively fulfill tasks and achieve results within assigned timelines.
A proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.
Qualifications
Bachelors' degree in Life Sciences, Engineering or related field, or equivalent combination of education and work experience.
8 years related experience in the relevant medical diagnostic/device industry, including 3 years of direct quality systems experience, regulatory affairs/compliance, project management, controlled documentation, quality data analytics, or change control.
Digital Quality Management System experience in design and development of Software as a Medical Device (SaMD) is preferred.
ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.
Familiarity with relevant international ISO Standards (e.g., 13485:2016, 14971:2019, 27001, etc.), and regulations (EU MDR/IVDR, 21 CFR - part 820). Direct experience working in a US FDA regulated environment required.
Understanding of GXP requirements preferred.
Competencies
Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development and manufacture of new products for our patients.
Be flexible with changing priorities/tasks and a desire for continuous improvement.
Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment.
Strong interpersonal/communication/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations.
Languages:
English Read Write Speak
Certifications & Licenses:
ASQ Certified Quality Engineer
CAPA
Certified Quality Engineer