Medical Device Lead Auditor

Company: National Standards Authority of Ireland
Location: Nashua
Posted on: May 14, 2022

Job Description:

Job Description Medical Devices Lead Auditor (Permanent Full Time) Recent experience as a Lead Auditor with a Notified Body and or MDSAP Auditing Organization. Perform regulatory (MDD, IVDD, AIMD, MDSAP, MDR, IVDR) QMS audits. We are a MDR designated Notified Body searching for experienced Notified Body/MDSAP Lead Auditors ready to make a change. Summary: Perform QMS/regulatory audits of clients per European Directives (AIMD, MDD, IVDD) and Regulations (MDR, IVDR), Medical Device Single Audit Program (MDSAP), International standards (ISO 13485, ISO 9001, etc.) as well as applicable guidance (e.g. MEDDEV) and internal procedures. Essential Responsibilities: Following a brief on-boarding process, as a NSAI Lead Auditor, in addition to conducting remote and on-site QMS audits, you will perform scheduling and planning activities including coordinating with clients and other auditors, arranging remote audit and travel logistics, carrying out post-audit activities including reviewing corrective actions, preparing/issuing reports and other audit documentation for technical and certification review, responding and communicating with other staff (Accounting, Customer Support, Certification, other auditors, Audit and Product Technical Reviewers, Management) and external organizations (e.g. client, competent authority, accreditation bodies) in a timely professional manner in all circumstances answering queries, replying to messages, and providing information regarding standard, guidance, regulation and technical requirements. As a NSAI Lead Auditor, you will attend mandatory and continuous professional development training, and carry out training plans in order to maintain device, technology, regulation, standard, and other internal competency requirements as well as provide training, mentoring, and monitoring of other staff. Education: University or Technical College Degree in a health care or science related field (biotechnology, molecular biology, biochemistry, microbiology, biomedical, chemical, mechanical, electrical, or software engineering, bioengineering, etc. A MS or PhD preferred. Experience: Minimum of 4 years of experience in an IVD, Active Implantable, and or medical device environment (design, risk management, manufacturing, QA, testing, regulatory) with two years in Quality Management. Previous recent experience with a Notified Body, MDSAP Auditing Organization, and or Certification Body as a QMS/Regulatory Lead Auditor. Previous recent industrial/notified body auditing experience including (one or more of) Sterilization, Packaging, Biomaterials/Coatings, Electromedical Device Safety, EMC, Software/Electronic Programmable Systems, Combinational (Biologic/Device or Medicinal/Device) Product preferred. Due to the pandemic, you will be primarily working remotely and must be legally residing anywhere in the USA with a robust home Internet service. This position will eventually involve travel within USA ( > 50%) and some international travel to and from clients via air and land, so proximity to a major airport is desirable. Fluency in English required, and other languages (Spanish, French) preferred. This position has an education requirement. You are strongly encouraged to submit a copy of your diploma(s) together with resume/CV, audit logs including competency codes, and cover letter. Work remotely from your home when not auditing at client locations. Job Type: Full-time Pay: $120,000.00 - $140,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Schedule: Monday to Friday Supplemental Pay: Bonus pay

Keywords: National Standards Authority of Ireland, Nashua , Medical Device Lead Auditor, Accounting, Auditing , Nashua, New Hampshire