Quality Assurance Manager- Internal Audit

Posting Date 3 weeks ago(11/15/2022 11:05 AM)
Requisition ID
2022-11870
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc - Bloomington
Category
Quality

Overview

The primary responsibilities of the role is to perform, plan, direct and manage the Internal Audit function for Cook Incorporated. This involves auditing the Quality Management System to ensure effectiveness and compliance to applicable external standards and regulations as well as to internal Cook Inc processes and procedures. This role will also be over the Quality Complaince process to ensure Cook Incorporated is up to date on external regulations and standards under which product is manufactured and distributed.

Responsibilities

- Manages day-to-day internal auditing and adherence assessment operations and provides leadership and direction to the functional team.
- Performs audits as lead auditor when necessary.
- Leads the maintenance, improvement and execution of the internal audit process.
- Manages the implementation, maintenance, improvement and execution of the adherence assessment program.
- Reviews and approves auditor qualifications, audit plans, audit reports, internal audit non-conformances, and closure of internal audit non-conformances.
- This role must be available to be on-site for all external audits and be able to get on-site within 2 hours for unscheduled audits.
- Manages external audits by scheduling the audit, submitting POs, running the backroom, working with SME for audit prep, and setting up audit log and communication spaces.
- Manages external audit responses with the assignee and ensure they are submitted on time.
- Communicates metrics and process measurements to organization.
- Create, maintain, adhere and communicate approved Audit schedule.
- Attend, present and provide data for meetings to include project and metric updates and reviews.
- Participate in hiring, interviewing and onboarding process of new hires.
- Responsible for performance management and annual reviews of direct reports.
- Authorization of concur, PTO request, department specific documents.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Qualifications

- Bachelor's degree in Engineering or Life Science; or experience of such kind and amount as to provide a comparable background.
- Minimum of 10 years experience in an FDA-regulated industry, preferably in a medical manufacturing environment.
- Minimum 5 years experience working with quality management system.
- Previous leadership experience, 5 years preferred.
- Proficient in Microsoft Word/Excel/Project/Outlook.

- This is a hybrid position which can require regular onsite visits, Must reside within a reasonable distance, within a 2 hour radius via car, of Cook Medical in Bloomington, Indiana. 

 

Physical Requirements:

- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to stand, walk, and communicate.
- Occasionally lifting with minimal exertion during shift.

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