Quality Supply Auditor
Company: Atrium Staffing
Location: Montvale
Posted on: June 13, 2022
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Job Description:
Our client operates worldwide and is a proven manufacturer
supporting the personal care and medical device space. They are
currently looking to hire a Quality Supply Auditor to join their
team.
Salary/Hourly Rate:
$95k - $110K -plus annual bonus
Position overview:
The Quality Supply Auditor is directly responsible for launching
and maintaining the internal and external audit programs. To ensure
the effectiveness of the program implemented, the Supplier Audit
Specialist will travel locally to client sites to ensure quality is
consistent with the company's expectations. The Quality Supply
Auditor will ensure compliance with FDA, Canadian, and EU medical
device regulations.
Responsibilities of the Quality Supply Auditor:
Launches and maintains the internal audit program.
Responsible for the external supplier audit program including
visitation of sites and speaking with the supplies' quality
leaders.
Provides training for members of the Quality team that specialize
in audits.
Develops the internal quality audit schedule including working with
cross-functional teams to prepare the audit agenda.
Responsible for conducting and closing audits and preparing audit
reports.
Audits CAPAs generated by the internal audit findings for
effectiveness.
Conducts external audits on suppliers, labs, and 3rd party
manufacturers with the support of a subject matter expert.
Initiates response forms addressing audit findings and communicates
updates with those involved.
Determines when audits and findings are to be closed or when they
require escalation and risk-level review.
Completes reporting for internal teams as it relates to the audit
findings.
Develops the certification and qualification programs for internal
auditors.
Supports with the writing and reviewing of procedures and
instructions of the quality management system.
Performs audit remediation.
Interfaces with Site Audit Leads to review and implements best
practices on a global scale.
Qualifications of the Quality Supply Auditor:
Medical device experience is required, and knowledge of
pharmaceutical regulations is preferred.
Five years of experience implementing and interpreting domestic and
international regulations for medical devices such as FDA 21CFR210,
211, 820, ISO 9001 and ISO 13485 standards, MDD, etc.
Proficiency in Microsoft Office Suite, SmartSolve, and Master
Control modules is preferred.
Lead Auditor certification is taken into consideration.
Education Requirements:
Bachelor's degree in a field related to QA or equivalent QA
certifications.
Benefits:
Atrium Care Package available, upon eligibility.
As a woman-owned firm, we value diversity. We are an equal
opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran
status, disability, genetic information or any other characteristic
protected by law. We will ensure that individuals with disabilities
are provided reasonable accommodation to participate in the job
application or interview process, to perform essential job
functions, and to receive other benefits and privileges of
employment. Please contact us to request an accommodation.
Keywords: Atrium Staffing, Tenafly , Quality Supply Auditor, Accounting, Auditing , Montvale, New Jersey
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