An internationally renowned pharmaceutical organisation is seeking to hire a Quality Auditor for their office in New Jersey. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
The Quality Auditor will perform medical device audits and assessments at company sites and vendors of medical device components, contract manufacturers, and service providers, which are involved in the supply of medical devices to global markets. They will lead the preparation, execution, and report of audits, drive audit report closure, including resolution of audit findings, liaise with appropriate site and quality oversight teams through all stages of the audit process, and contribute to enabling a culture of excellence and continuous improvement of the company's Quality Management System.
- Serving as subject matter expert lead of medical device and combination product audits and assessments of company sites, contract manufacturers, suppliers, and service providers to ensure compliance with all applicable global medical device regulations and company standards
- Utilizing in-depth technical experience and knowledge of international regulatory requirements, to assess varied medical device and combination product Quality Management Systems and operations
- Leading audit preparation activities, including assessment of medical device regulatory requirements, Quality Agreement requirements, previous audit outcomes and other focus areas of the company facility or vendor to be audited.
- Leading audit execution activities, including in-depth evaluation of the adequacy of personnel, documentation, facilities and equipment involved in the design/development, manufacturing, packaging, testing, storage and distribution of medical devices, and the compliance of the auditee's operations with Quality Management System requirements, Quality Agreement requirements, and company expectations.
- Leading audit report activities, identifying properly levelled audit findings, including escalation through the notification to management process of issues of elevated significance that could lead to non-compliant design/development, manufacturing, testing, or distribution of medical devices.
- Leading audit closure activities, collaborating with the auditee in the review, approval, and implementation as appropriate of meaningful corrective action plans to audit findings.
- Supporting the mentoring of other auditors in device regulatory requirements during planned audits and during other hands-on experiential audit simulation activities as applicable.
- Developing cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, critical thinking and innovative problem solving
- Leading or participating in assessments at company sites and contract manufacturers in preparation for upcoming medical device regulatory inspections
Skills and Requirements:
- Bachelor's degree in Engineering or other closely related technical degree, Master's Degree in technical field is preferred.
- 10+ years of related experience in a medical device design, development, manufacturing, or technical quality engineering.
- 5+ years of documented medical device auditor experience in a global role, with medical device auditor certification, e.g., RABQSA or TPECS.
- In-depth knowledge of major medical device regulations for the United States (QSR and MDSAP), Canada (CMDCAS), Europe (MDD and CE Marking), China (NMPA), Brazil and Australia, as well as internationally recognized Quality Management System auditing standards and procedures.
- Proficiency with US FDA combination product regulatory requirements.
- Experience in pharmaceutical Quality Management System and pharmaceutical auditing.
- Experience auditing device component manufacturers.
- Proficiency in emerging medical device regulations.
- Proficiency reviewing technical dossiers to the requirements of 93/42/EEC (MDD).
- Understanding of global medical device post-market surveillance requirements.
- ASQ Certification such as CQE, CQA is desirable.
- FDA/Notified Body experience is desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.