INGENYX- 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, specializing in extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins.

Expected travel: Up to 25%

About the Role

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, focusing 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 position serves as a senior quality partner to Engineering, Manufacturing, Operations, Regulatory, Supplier Quality, and Commercial teams to ensure products and processes are robust, compliant, scalable, and aligned with customer and quality system requirements.

Responsibilities

• 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 requiring broad analysis of product performance, process capability, quality data, customer requirements, and regulatory expectations.
• 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.
• 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 creation and maintenance of technical and quality documentation including drawings, specifications, procedures, inspection methods, control plans, risk management files, traceability matrices, validation protocols/reports, verification protocols/reports, and design control documentation.
• Provide quality oversight for process validations, equipment validations, test method validations, sterilization-related assessments, biocompatibility assessments, packaging or labeling changes, and other quality or regulatory deliverables.
• Independently assess the impact of product, process, material, supplier, equipment, labeling, and manufacturing changes and define appropriate quality deliverables based on risk, regulation, and quality system requirements.
• Collaborate with Engineering to develop practical validation and verification strategies that are scientifically sound, statistically justified, compliant, and aligned with business and customer needs.
• Lead complex root cause investigations related to nonconformances, CAPAs, complaints, audit findings, process issues, supplier issues, customer concerns, and post-market quality signals.
• Apply structured problem-solving methods such as 5-Why, Fishbone, DMAIC, PDCA, statistical analysis, process mapping, and other appropriate quality tools.
• Ensure root cause investigations identify systemic causes and result in sustainable corrective and preventive actions.
• Partner directly with Manufacturing, Engineering, Operations, and Supplier Quality to resolve quality issues impacting materials, assembly, functional performance, inspection, process capability, equipment, and product release.
• Analyze quality data, complaint trends, nonconformance trends, process performance, yield, scrap, inspection results, and other metrics to identify emerging risks and prioritize improvement efforts.
• Support production environments through hands-on issue resolution, change implementation, defect reduction, containment, disposition support, and continuous improvement.
• Evaluate process controls, inspection methods, acceptance criteria, sampling approaches, and manufacturing procedures to ensure they are effective, risk-based, and aligned with product requirements.
• Interpret applicable regulatory and standard requirements and translate them into practical and effective quality system implementation.
• Support compliance with applicable medical device regulations and standards, including FDA QSR / 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other applicable global regulatory requirements.
• Lead or support quality system improvements based on operational risk, audit observations, recurring issues, customer feedback, or changes in regulatory expectations.
• Support internal audits, external audits, FDA inspections, ISO audits, customer audits, and audit readiness activities.
• Independently assess quality system gaps and recommend improvements that increase clarity, usability, compliance, and effectiveness.
• Ensure projects, investigations, changes, validations, and quality records are developed and documented in compliance with Teleflex Quality System requirements.
• Collaborate with Regulatory, Engineering, Manufacturing, and Operations to ensure quality and compliance requirements are understood early and incorporated into project planning and execution.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline required.
• Minimum 6 years of experience in Quality, Manufacturing Engineering, Development Engineering, or a related technical quality role within the medical device industry or a similarly regulated manufacturing environment (7+ years preferred).
• Minimum 5 years of experience supporting medical device manufacturing, design control, process validation, sustaining engineering, or quality system activities (6+ years preferred).
• Demonstrated experience independently leading complex quality investigations, CAPAs, nonconformances, complaints, validations, change assessments, or quality improvement projects.
• Experience supporting design and development, manufacturing operations, supplier changes, post-market quality activities, and customer-facing quality issues.
• Experience working hands-on in a production or manufacturing environment is highly preferred.
• Experience working in a medical device OEM, CDMO, or customer-facing manufacturing environment preferred.

Skills

• Strong knowledge of:
  • Regulated industries (FDA QSR (21 CFR 820), ISO 13485, EU MDR, MDSAP).
  • Risk management principles and methodologies, including DFMEA, PFMEA, hazard analysis, and risk control effectiveness.
  • Applied statistical analysis and data-driven decision making.
  • Process validation principles, including IQ/OQ/PQ, test method validation, statistical justification, sampling rationale, and process capability.
  • Root cause analysis and structured problem-solving methods.
  • Manufacturing process controls, inspection strategies, acceptance criteria, nonconformance handling, and corrective/preventive action systems.
  • Medical device documentation expectations, including procedures, specifications, drawings, validation records, risk files, design history files, and change records.
• Ability to:
  • Interpret regulatory requirements beyond procedural checklists and apply them to real product, process, and business situations.
  • Clearly define quality problems, technical risks, and compliance requirements before selecting tools or solutions.
  • Make sound risk-based decisions in complex or ambiguous situations.
  • Lead complex investigations and projects with minimal guidance.
  • Communicate effectively with internal stakeholders, external customers, suppliers, auditors, and leadership.
  • Translate quality and regulatory expectations into practical execution plans.
  • Balance compliance, patient safety, customer needs, operational realities, and business impact.
  • Influence peers and cross-functional partners without relying solely on formal authority.
• Practical experience using quality and engineering tools such as:
  • Root cause analysis methodologies (e.g., 5 Why, Fishbone).
  • DMAIC, PDCA Cycles, and structured problem solving.
  • Statistical analysis and data-driven decision making.

Preferred Qualifications

• Experience aligned with ASQ Quality Engineering and Quality Assurance principles.
• ASQ certifications (CQE, CQA, Six Sigma Green or Black Belt).
• Experience applying quality engineering principles in a regulated medical device environment.