Sr. Quality Engineer

On-X Life Technologies, Inc.; Austin (TX); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

5 weeks PTO

10 paid holidays

Medical, dental, vision insurance

401(k) with up to 4% company match

Employee Stock Purchase Plan

Job summary

Artivion, Inc. in Austin, TX seeks a Quality Engineer to lead NPD transfers, validate processes, and ensure compliance with FDA and ISO standards. You will create and approve validation protocols, manage Design History File documentation, and drive CAPA actions.

This onsite role requires strong statistical and quality system knowledge. Minimum 4 years in a regulated medical device environment with GMP/ISO experience is expected, along with a relevant engineering or science degree.

Qualifications

• Bachelor's degree in an Engineering or science field.
• 4+ years hands-on experience in FDA-regulated industry with GMP/ISO knowledge.
• Knowledge of statistical methods and acceptance sampling in regulated environments.
• Ability to design/execute validations and develop report packages for equipment, processes, software.

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 corrective/preventive actions.
• Perform Internal or Supplier Quality System Audits.
• Develop Validation Master Plans and Validation Project Plans.
• Develop and document qualifications/validations to ensure products are reliable, safe, effective.

Skills

Quality Engineering

NPD leadership

FDA regulatory knowledge

Statistical methods

CAPA & non-conformances

Education

Bachelor's degree in Engineering or science

4+ years in FDA/regulatory medical device 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, 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 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.

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: Enjoy5 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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.