Quality Assurance Auditor

Posted August 26, 2011
Business MED Institute, Inc.
Purdue Research Park of West Lafayette,
n/a
Position Type Full Time
Start Date Immediate Availability
Required Experience 3 years

Duties / Responsibilities

The successful candidate will have an understanding of working in an FDA regulated environment and have the desire to interact with technical staff. The candidate must have the confidence to communicate errors to staff in a positive manner.

  • Review and approve protocols, reports, project documentation, validation documentation, and regulatory submissions for accuracy.
  • Ensure MED deliverables are compliant with medical device regulations.
  • Report noncompliance and quality issues to management.
  • Perform audits of projects and data.
  • Assess impact of proposed revisions to procedures and changes to processes.
  • Train staff on Quality System processes such as CAPA, change control, and documentation practices.

Requirements / Qualifications

  • B.S. in science or engineering or 3 years of relevant experience.
  • Detail oriented.
  • Effective and confident communication skills.
  • Ability to manage multiple projects along with changing priorities.
  • Ability to handle conflict in a professional manner.
  • Working knowledge of GXP or ISO 13485 desirable.

Company Description

MED Institute, Inc. was established as a resource for Cook Group companies to identify and develop new medical product concepts. This includes new product discovery, prototype development, nonclinical testing, clinical study management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and administrative professionals.

Other

Benefits include 401k and profit sharing plans, health, dental, life and optical insurance, eight paid holidays per year, and vacation.

MED Institute is an Equal Opportunity Employer (EOE).

Application Instructions

Please submit your resume to HR@medinst.com.

We accept Word documents and PDF's.