Risk Management Associate, FDA Regulated Industry

Posted Date 3 weeks ago(2/5/2018 12:17 PM)
Job ID
2018-1934
Job Location
US-GA-Kennesaw
# of Openings
1
Category
Quality Assurance

Introduction

Is This The Role For You?

 

We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

 

If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

Position Overview

Under the direction of the Director, Quality Engineering and with minimal supervision, assist with maintaining the Risk Management Program.

Responsibilities

  • Ensure that all policies and procedures for the Risk Management Program are maintained.

 

  • Establish and/or maintain Risk Management Files to support product lines and corporate projects.

 

  • Work with project teams and necessary departments to identify appropriate process and product hazards, probabilities, severities and mitigations for Risk Analyses.

 

  • Ensure periodic reviews of Risk Management Files are performed according to schedule.

 

  • Evaluate labeling, process and/or product changes for their impact to the current Risk Management Files.

 

  • Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files.

 

  • Provide requested investigation reports/evaluations to other departments in a timely manner.

 

  • Remain knowledgeable of all of the applicable standards, regulations and procedures related to tissues and devices, both internal and external.

 

  • Support Quality Engineering efforts as appropriate.

Qualifications

 

  • Bachelor’s Degree preferably in the Life Sciences or engineering field

 

  • Minimum of 2 years of experience in an FDA regulatory industry with knowledge of ISO, FDA and the Quality System Regulations and with familiarity of the regulations and requirements for risk management for medical devices

 

  • Must be able to prioritize, manage and follow-up on numerous projects and activities

 

  • Must exhibit effective written and verbal communication skills

 

  • Must be detail oriented and exhibit a high degree of flexibility and initiative

 

  • Must have personal computer skills, i.e., word processing, spreadsheets and general data analysis

 

  • Must be a goal-oriented team player, open-minded and flexible with ability to adapt easily and accept new ideas quickly

 

  • Ability to evaluate, analyze and summarize large volumes of data and technical material efficiently

 

  • Must exhibit excellent judgment by considering all pertinent factors, making decisions quickly and carefully, and accepting responsibility for the decisions

 

  • Must be reliable in following through and completing assignments

 

  • Must be a self-starter, alert for situations requiring action, confident of being able to think situations through

 

  • Ability to work independently with minimal supervision

Company Info

Who We Are.

 

CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

 

CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

 

CryoLife is an Equal Opportunity/Affirmative Action employer.

CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.

 

Reasonable Accommodations
CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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