Senior Software Quality Engineer

1 month ago
Job ID
2017-1866
US-GA-Kennesaw
# of Openings
1
Category
Engineering

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

Utilize Quality Engineering and Quality Assurance techniques and expertise to provide functional support for new product development and product line support. Ensure 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

  • Manage an engineering staff to ensure implementation of Quality Engineering duties and responsibilities. Hire, train, develop and manage exempt and non-exempt employees as assigned. Provide leadership within the Quality Engineering group in an effort to ensure technical and personal development of all personnel within Quality Engineering.

 

  • Assist in the implementation of corporate policies and procedures relating to quality, project management, process development and Quality System Regulation/ISO compliance by periodically reviewing specifications for functionality and initiating the required changes, establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures.

 

  • Review IT Application Change Requests to assess impact of the change and determine verification/validation strategies.

 

  • Manage Software project scheduling and resource requirements. Assist in the development of project schedules, including the identification of project tasks and associated timelines.

 

  • Review requirements documentation to ensure that requirements stated are correct, unambiguous and verifiable.

 

  • Lead discussions with IT to evaluate system interfaces, operational requirements and performance requirements of overall system.

 

  • Define test methods and create test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions.

 

  • Recommend design improvements or corrections to the User and/or IT throughout the development process, and maintain effective communication with the User and IT on project limitation, capability, performance requirement and hardware interface changes.

 

  • Execute test plans and create test reports to describe program evaluation, testing, and correction.

 

  • Monitor program performance after implementation to prevent reoccurrence of program operating problems and ensure efficiency of operation.

 

  • Manage the implementation of off-the-shelf software programs, and support manufacturing during the implementation of software used in production.

 

  • Define process requirements that align with industry best practices and regulatory guidance to aid in data gathering and test method execution.

 

  • Support clinical studies by validating data collection processes.

 

  • Lead risk management meetings.

 

  • Provide Quality Engineering technical leadership in resolving quality issues, and analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.

 

  • Create, review and approve documents required for the Design History File, as necessary.

 

  • 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.

 

  • Develop, conduct, and document software validations to ensure products processed are proven to be reliable, safe, and effective prior to release.

 

  • Assess equipment changes for software validation needs, and coordinate software validation activities, and scheduling, in support of corporate projects.

 

  • Ensure appropriate training and resource management of any staff assigned.

 

  • Quality Engineering duties include the following:

 

    • Partner with R&D and other cross functional groups to ensure successful development and commercial launch of new products and to ensure the proper application of design controls and risk management and the investigation/correction of design failures/challenges.

 

    • Review and approve design input requirements as appropriate and the translation of input requirements into design output documents as appropriate.

 

    • 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. Responsibility for ensuring Quality compliance throughout affected areas.

 

    • Conduct investigations, bounding, documentation, review and approval of non-conformances, CAPA’s and customer complaints as necessary.

Qualifications

  • Minimum of a Bachelor’s degree in an Engineering field or equivalent experience

 

  • 6-10 years of 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

 

  • Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical preferred

 

  • Specific experience with software 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

 

  • Ability to understand the Company’s Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency and ability to interface with regulatory bodies to present technical information

 

  • ASQ CQE/CQA Certification preferred but not required

 

  • Supervisory experience preferred but not required

 

  • Personal computer skills, i.e., word processing, spreadsheets, data analysis

 

  • Must be a self-starter with ability to work independently with minimal supervision

 

  • Must have excellent written and verbal expression and must be a goal-oriented team player

 

  • In-depth knowledge of FDA, ISO and AATB (preferred) regulations, guidelines and standards

 

  • Must able to adapt easily, accept new ideas quickly and effectively manage and prioritize numerous projects and responsibilities

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed