The Senior Quality Assurance Specialist - Medical Device is a senior technical expert in Quality Assurance, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department and providing technical mentoring to the Quality Assurance staff. This role requires advanced technical knowledge in regulations and industry standards in the conduct of clinical trial operations with a strong understanding of research ethics and privacy.
The focus of this role is Medical Device Quality Assurance. The Senior Quality Assurance Specialist - Medical Device has knowledge of regulations and standards governing medical Imaging, AI/machine learning and software as a medical device (SaMD).
Quality Planning, Execution and Oversight
Develop, implement, and track compliance of QA plans (study, internal process and annual).Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders. Monitor, evaluate quality indicators, QA reports and audit responses. Support study operational teams with resolution of escalated issues.Identify quality risks and work with leaders to design mitigation strategies.Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities.
Regulatory, Ethics and Privacy Support
Act as a senior representative of Quality at internal and external meetings.Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics, and privacy inquiries.Remain knowledgeable and current on industry environment and global regulatory legislation governing clinical research, medical devices and pharmaceuticals.Mentor other QA staff in the support of the development of standard operating procedures.Technical Expertise Mentorship and Training
Serve as a technical role model, motivator, and mentor to the members of the quality team.Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs.Develop and provide training both within the department and external to it.Qualifications
Minimum of a bachelor's degree with 7-9 years of related experience and on the go trainingFluent in the reading, writing, and speaking of English (other language skills preferred)Most senior individual level contributor position in the department. Determines own pace of work and is expected to operate independently with little support from Director, QA. Major decisions impacting the department or organization are escalated.
Additional Knowledge/Skills
Certification in GCP, ISO 13485, or MDSAP, auditing Knowledge of regulations and standards governing medical imaging, AI/machine learning and software as a medical device (SaMD) Strong written, verbal communication and presentation skillsProven Critical thinking and analytical skills Strong change management skills and critical thinking skillsExperience working and collaborating in cross-functional global team environmentAbility to influence and build consensus without authority Ability to work independently and self-motivate Strong relationship-building and interpersonal skillsKnowledgeable of medical imaging and clinical research industry regulations and standardsWorking Conditions
Home-based*Accommodations for job applicants with disabilities are available