Senior Quality Engineer

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.
• Coordinate, execute, and schedule validation activities in support of corporate projects.
• Interface with manufacturing facilities as required.

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.

Benefits & Perks

• 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.
• Retailer 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 rate and share in our company’s success.
• Work-Life Balance: Benefit from a consistent and predictable work schedule.
• 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.