Quality Assurance Specialist II

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: Establish and maintain Quality Systems that comply with regulations and standards. Review all records associated with the processing of human tissue and production of medical device products and make final decisions to release product for distribution. Exercise discretion to reduce waste and variability in processes. Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations. Ensure that all areas identified as “Principal Responsibilities” are accomplished in an efficient and professional manner.Responsibilities:

• Increase productivity and revenues by optimizing processes and work flows through experience and knowledge obtained.
• Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations.
• Work with management to formulate and use authority to implement new operating practices to improve processes.
• Engage with other applicable personnel to clarify, collaborate, and/or correct the information provided, and to solicit required information.
• Support and assist with other department’s projects, documentation requirements, or other needs that are required of Quality Assurance.
• Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished.
• Perform investigation relative to the Field Assurance complaint review process and nonconformance investigations.
• Assist management with training functions as deemed necessary to ensure Quality personnel are current to updated standards, procedures, and specifications.
• Inform supervisors and associates of significant new information, company policies and procedures as they become available, and provide such information in a manner that encourages willing cooperation and support.
• Perform process and procedure audits to ensure compliance, and where necessary, initiate the activity required to implement changes.
• Provide input to management to facilitate the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job. Initiate change requests and change orders.
• Effectively complete “other” functions that may be assigned by management.

Qualifications:

• Bachelor’s Degree in the Life Sciences or other scientific field or equivalent work experience.
• Minimum 2 years’ experience in Quality preferred.
• Previous experience in a regulated industry is preferred.
• Must be legally authorized to work in the United States
• Must be willing to submit to a pre-employment background check and drug screen
• Must be at least 18 years of age

Company Info:Who We Are.
CryoLife is one of the world’s leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.
CryoLife is an Equal Opportunity/Affirmative Action employer.
CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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.