Sr. Quality Engineer

Artivion, Inc.; Austin (TX); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

5 weeks PTO and 10 holidays

Health, dental, vision insurance

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

EAP and legal benefits

Job summary

Artivion, Inc. Austin facility specializes in On-X Mechanical Heart Valves. The Quality Engineering role focuses on applying QA techniques to new product development and ongoing product support, ensuring compliance with GMP, QSR, and ISO standards during receipt, storage, and distribution of materials.

The ideal candidate will lead validation efforts, perform risk assessments, and drive CAPA programs across cross-functional teams to ensure safe, effective medical devices reach the market.

Qualifications

• Bachelor's degree in Engineering or science field or equivalent work experience.
• 4+ years hands-on quality engineering in FDA-regulated environments (medical device/pharma).
• Knowledge of GMP, QSR, ISO standards; statistical methods and acceptance sampling.

Responsibilities

• Provide QE leadership for NPD and transfer to manufacturing.
• Drive quality issue resolution and CAPA for products and processes.
• Create/approve validation protocols and DHF documents.
• Lead risk management and FMEA documentation.
• Coordinate validation activities across facilities and projects.
• Interface with manufacturing sites to ensure quality compliance.

Skills

Quality Systems

Statistical Methods

Acceptance Sampling

Design Controls

Risk Management

FMEA

Verifications & Validations

CAPA investigations

Education

Bachelor's degree in Engineering or science

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, visit our website at www.artivion.com.

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 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 andcompleted 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.

QE duties include:

• 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.

Qualifications:

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

Benefits & Perks:

We offer a comprehensive and competitive benefits package designed to support your health, financial well-being, and work-life balance:

• Generous Time Off: Enjoy 5 weeks of Paid Time Off (PTO), accrued throughout the year,plus 10 paid company holidays
• Health & Wellness: Comprehensive medical, dental, and vision coverage, along with life insurance and supplemental benefits
• Retirement Planning:401(k) with up to a 4% company match(Traditional and Roth options available)
• Employee Stock Purchase Plan:Purchase Artivion stock at a discounted rateand share in our company’s success
• Work-Life Balance: Benefit from a consistent and predictable work schedule
• Education Support:Tuition reimbursement to support your continued growth and development
• Employee Assistance Program (EAP): Access confidential resources for personal, financial, and emotional well-being
• Legal Benefits (LegalShield): Includes legal consultation, document review, will preparation, and 24/7 emergency access
• Financial Wellness: Access tools and resources through the Truist Momentum program
• Employee Discounts: Enjoy savings through Working Advantage, offering discounts on travel, entertainment, and more
• Efficient Hiring Process: We value your time and offer a streamlined interview process with timely feedback and decisions

Please Note: This is an onsite position based out of our manufacturing facility in Austin, Texas.