Quality Engineer I (On-Site - Austin, TX)

On-X Life Technologies, Inc.; Austin (TX); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life Insurance

401(k) plan

ESPP

10 paid holidays

Competitive PTO

Tuition reimbursement

Job summary

Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to support new product development and existing product lines with Quality Engineering and Quality Assurance techniques.

You will analyze non-conformances, lead CAPA activities, validate equipment, processes, and software, and collaborate with R&D and manufacturing to ensure products are reliable, safe, and compliant prior to release.

Qualifications

• Bachelor’s degree in engineering or equivalent experience.
• 0–2 years experience in FDA-regulated industries with knowledge of GMP, QSR, and ISO standards.

Responsibilities

• Provide Quality Engineering 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 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 products are proven reliable, safe, and effective prior to release.
• QE duties include: Partner with R&D and cross-functional groups to support development and commercial launch; apply design controls, risk management, and investigation/correction of design failures; sampling plans and acceptance sampling for manufacturing data; develop Risk Management Documents including FMEA's; review and validate Test Methods; interface with manufacturing facilities; conduct investigations, CAPAs and customer complaints.

Education

Bachelor's degree in engineering field

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, click here.

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.