Quality Engineer II

Quality Engineer II

At Life Net Health, you are the advantage. Every day, you help us to save lives, restore health, and bring hope to patients and families around the world. At Life Net Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.

Together, we are united by a mission greater than ourselves, a purpose rooted in healing.

As a Quality Engineer II, you'll play a vital role in advancing our mission. In this position, you'll be responsible for leading quality engineering for product development and sustaining engineering, driving quality compliance, risk management, and continuous improvement in the medical device/biologics/tissue combination product industry. This role involves leading cross-functional initiatives and serving as the primary Quality Engineering representative in design and production efforts, ensuring strategic alignment with regulatory and business objectives while partnering with cross-functional teams to ensure that production processes and outputs meet all applicable regulatory requirements, including but not limited to FDA 21 CFR Part 820, 21 CFR Part 1271, ISO 13485, and ISO 14971.

This role will also play a critical role in risk management, design verification and validation (V&V), production and continuous improvement initiatives.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

Assigned to either Production or Design core functions within the Quality Engineering Department.

Production:

• Lead Engineer for ensuring compliance with regulatory requirements and company standards in all production activities.
• Serve as the lead Quality Engineering authority with Procurement, Receiving, and Business Units to meet component requirements and improve quality control inspection methods.
• Serve as the lead Quality Engineering authority for management of NCRs, CAPAs, Deviations, and other Quality System elements.
• Manage nonconforming materials and ensure proper documentation and communication for resolution.
• Develop and implement quality control inspection plans and ensure First Article Inspections for new or modified articles are completed.
• Quality Engineering authority for Supplier Quality activities, including selection, evaluation, and performance reviews, while providing input on product and process development for manufacturability and compliance.

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Design:

• Serve as the lead Quality Engineering authority across the product development lifecycle, including design development, reviews, and post market activities and driving quality strategy in cross-functional team, from concept through design transfer and commercialization.
• Ensure that all design control activities are conducted in compliance with regulatory requirements and company standards.
• Quality Engineering authority for design inputs, design outputs, design verification and validation plans/reports, and design transfer activities.
• Quality Engineering authority in design reviews, ensuring that design risks are identified, assessed, and mitigated appropriately.
• Quality Engineering authority on product and process development to ensure manufacturability, reliability, and compliance with quality standards.

Verification and Validation (V&V)

Ensures design verification and validation protocols and associated reports for products and production meet defined quality requirements and specifications

• Oversees R&D, manufacturing, processing, design quality and other teams to ensure that V&V activities are conducted in compliance with regulatory requirements
• Quality Engineering authority for analytical methods, processes, and equipment to ensure that testing methods are accurate, reliable, and suitable for their intended purpose.
• Lead and supports continuous improvement efforts including enhancing testing processes, methodologies, and tools.
• Quality Engineering authority for V&V data to ensure that products are safe, effective, and meet customer and regulatory expectations.

Sustaining Engineering

• Provides quality engineering leadership for sustaining engineering activities, including product changes, process improvements, and design modifications.
• Oversee and approve quality risk assessments for product and process changes; ensure product quality and compliance with appropriate change controls and implementation
• Drives strategic initiatives to enhance quality system robustness
• Support post-market activities, including complaint investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs).

Risk Management

• Ensure that risk management activities are integrated into the production control process and are continuously monitored throughout the product lifecycle in accordance with ISO 14971.
• Leads and facilitates risk assessment for product and process design or changes to support the Process Failure Mode and Effects Analysis (PFMEA) and other risk assessment tools to identify potential risks…