Quality Supply Auditor

Company: Atrium Staffing
Location: Montvale
Posted on: June 13, 2022

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