Sr. Quality Engineer

CryoLife•Austin, TX

32d

About The Position

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. Ensures that all areas outlined under “Principal Responsibilities” are accomplished in an efficient and professional manner to support Artivion, Inc.

Requirements

Minimum of a Bachelor's degree in an Engineering or science field, or equivalent work experience.
Minimum of 4 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.
Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical.
Specific experience designing, preparing, executing, and/or 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.
Ability to understand Artivion Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
Ability to interface with regulatory bodies to present technical information.

Nice To Haves

ASQ, CQE, CQA Certification preferred, but not required.

Responsibilities

Provide Quality Engineering project leadership for NPD and transfer to manufacturing.
Provide Quality Engineering technical leadership in resolving quality issues.
Create, review and approve Protocols, Process and Product Validations.
Create, review and approve 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.
Develop, conduct, and document qualifications/validations to ensure products processed are proven to be reliable, safe, and effective prior to release.
Assess equipment changes for validation needs.
Coordinate, execute, and schedule validation activities in support of corporate projects.
Interface with manufacturing facilities as required.
Effectively complete “other” functions that may be assigned.
Partner with cross functional groups to ensure successful development and commercial launch of new products.
Partner with cross functional groups to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
Review and approve design input requirements as appropriate.
Review and approve 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.
Lead in development of risk management documents to include FMEA's, as appropriate.
Review and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements.
Review, approve, and validate Test Methods.
Conduct investigations, bounding, documentation, review and approval of non-conformances, CAPA's and customer complaints as necessary.
Other responsibilities as assigned.