Medical Device Lead Auditor
Company: National Standards Authority of Ireland
Location: Nashua
Posted on: May 14, 2022
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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
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