Quality Engineer I

Regulatory Jobs; Austin (TX); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vis

Life Insurance

Supplemental Benefits

401(k) with Traditional and Roth

Employee Stock Purchase Plan (ESPP)

10 Paid Company Holidays

Competitive PTO plan

Tuition Reimbursement

Job summary

Artivion, Inc. is seeking a Quality Engineer I to support new product development and manufacturing transfers at the Austin facility.

You will apply quality engineering and QA techniques to ensure compliance with federal and ISO standards throughout receipt, storage, manufacture and distribution. Responsibilities include resolving quality issues, performing non-conformance analysis, and developing robust validation plans for equipment, processes and software used in testing and storage.

Qualifications

• Bachelor’s Degree in engineering or equivalent experience.
• 0-2 years experience in FDA-regulated industry with knowledge of GMP, Quality System Regulations, and ISO standards.

Responsibilities

• Provide QE project support for NPD and transfer to manufacturing.
• Provide QE technical support to resolve quality issues.
• Analyze process/product non-conformances and implement corrective and preventive actions (CAPA).
• Prepare, execute, and analyze validations for equipment, processes, and software used in testing, processing, storing, and distribution.
• Collect, statistically analyze, and develop report packages to support validations and studies.
• Assist in development of qualifications and validations to ensure products are reliable, safe, and effective prior to release.
• Collaborate with R&D and cross-functional groups to support development and launch; apply design controls and risk management.
• Review, approve, and validate Test Methods; interface with manufacturing facilities; conduct investigations and CAPA closures as needed.

Skills

Statistical analysis

CAPA management

Risk management

Validation

Design controls

Quality engineering

Education

Bachelor’s degree in engineering or equivalent experience

Job description

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, .

Position Objective

The Quality Engineer I utilizes Quality Engineering and Quality Assurance techniques 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.
• Analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.
• 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.
• Assist in the development, implementation, and documentation of qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release.
• 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.
  • 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.
  • Assist in Development of Risk Management Documents to include FMEA’s.
  • Review, approve, and validate Test Methods.
  • Interface with manufacturing facilities as required.
  • Conduct investigations, bounding, documentation, and review of non-conformances, CAPA’s and customer complaints as necessary.

Other responsibilities as assigned.

Qualifications

• Minimum of a Bachelor’s Degree in engineering field or equivalent experience.
• 0-2 years 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.

Benefits

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement

Equal Employment Opportunity Employer (EEO)

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.