Quality Engineer II

CryoLife, Inc. Kennesaw, GA
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

This position utilizes Quality Engineering and Quality Assurance techniques and expertise to provide functional support for new product development and product line support. This position also ensures that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Responsibilities
  • Provide Quality Engineering project support for NPD and transfer to manufacturing.
  • Provide Quality Engineering technical support to assist in resolving quality issues.
  • Create and review Protocols, Process and Product Validations.
  • Create and review documents required for the Design History File.
  • Analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.
  • Perform Internal or Supplier Quality System Audits, as assigned.
  • Develop Validation Master Plans and Validation Project Plans to ensure that all validation tasks required supporting operational areas and corporate projects are identified and completed within established time frames.
  • Design, prepare, execute, and analyze validations to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products.
  • Collect, statistically analyze, and develop report packages to support validations and engineering studies.
  • Develop, conduct, and document qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release.
  • Assess equipment changes for validation needs.
  • Coordinate validation activities, and scheduling, in support of corporate projects.
  • Interface with manufacturing facilities as required.
  • Effectively complete “other” functions that may be assigned.
  • QE duties include:
  • Partner with R&D and other cross functional groups to support successful development and commercial launch of new products.
  • Partner with R&D and other cross functional groups to support the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
  • Support determination of design input requirements as appropriate.
  • Review the translation of Input requirements into design output documents.
  • Accountability for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. including assessing, applying and interpreting acceptance sampling for manufacturing data. Will take responsibility for ensuring Quality compliance throughout affected areas.
  • Assist in Development of Risk Management Documents to include FMEA’s.
  • Review, approve, and validate Test Methods.
  • Conduct investigations, bounding, documentation, and review of non-conformances, CAPA’s and customer complaints as necessary.
Qualifications
  • Minimum of a Bachelor’s Degree, preferably in an Engineering field or Life Science.
  • Minimum of 3 years hands-on experience; preferably in a FDA regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
  • Specific experience designing, preparing, executing, and statistically analyzing validations, as well as developing report packages, to approve equipment, processes, and software used in the receipt, testing, processing, storing, and distribution of raw materials, components, and tissues/products.
  • Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical.
  • ASQ, CQE, CQA certification preferred, not required.
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 [Click Here to Email Your Resumé] 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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