INGENYX- Sr. Quality Engineer, Devices

Sr. Quality Engineer, Devices

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging.

We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

The Sr. Quality Engineer, Devices is responsible for leading and overseeing complex quality engineering activities within the OEM Performance Fibers Devices Value Stream. This role supports contract manufactured and Teleflex-owned suture products and devices, with a focus on sustaining quality, design and development support, manufacturing quality, customer and regulatory driven projects, supplier and material changes, process validation, complaint/nonconformance/CAPA resolution, and continuous improvement.

The Sr. Quality Engineer, Devices is expected to operate with a high level of independence, technical judgment, and business ownership. This position serves as a senior quality partner to Engineering, Manufacturing, Operations, Regulatory, Supplier Quality, and Commercial teams to ensure that products and processes are robust, compliant, scalable, and aligned with customer and quality system requirements. The role requires the ability to translate regulatory and quality system requirements into practical, risk-based execution that supports patient safety, compliance, customer satisfaction, and operational performance.

The Sr. Quality Engineer, Devices is expected to have strong proficiency in medical device quality systems, design control, process validation, risk management, root cause analysis, statistical methods, manufacturing controls, and project leadership. This role will lead and support complex quality deliverables with minimal guidance, provide technical direction to less senior quality engineers and cross-functional partners, and serve as a Quality Subject Matter Expert within the Devices Value Stream.

Principal Responsibilities

Quality Engineering & Technical Leadership

• Lead and independently own complex quality engineering activities across design and development, sustaining engineering, manufacturing, suppliers, and post-market quality.
• Serve as a senior Quality Subject Matter Expert for Devices Value Stream products, processes, manufacturing controls, quality system requirements, and customer quality expectations.
• Provide quality leadership for high-complexity projects including regulatory and compliance driven changes, supplier changes, material changes, design changes, cost improvement initiatives, process improvements, validations, and product or capability development activities.
• Apply risk-based decision making to complex quality and compliance challenges, balancing regulatory requirements, patient safety, customer expectations, business needs, and operational practicality.
• Partner with Engineering and Manufacturing to ensure Teleflex Medical OEM suture products and devices meet customer requirements, internal specifications, quality system requirements, and applicable regulatory expectations.
• Work on complex, high-impact issues where broad analysis of product performance, process capability, quality data, customer requirements, and regulatory expectations is required.
• Identify, prioritize, and lead quality improvement opportunities that reduce risk, improve process robustness, reduce variation, improve scrap rates, increase yield, and strengthen overall value stream performance.
• Act as a consistent quality presence throughout development, manufacturing, change implementation, and post-market activities, not solely at the review or approval stage.

Design Control, Risk Management & Technical Quality Execution

• Lead and support design control activities for new product, sustaining, and change projects, including design reviews, design inputs/outputs, verification and validation planning, traceability, design transfer, and design history file documentation.
• Serve as a technical quality resource for risk management activities, including DFMEA, PFMEA, hazard analysis, risk assessment, RACTs, risk acceptability, residual risk evaluation, and risk control effectiveness.
• Develop, review, and approve quality plans, regulatory compliance strategies, test strategies, inspection strategies, and validation approaches for complex projects.
• Lead or support…