INGENYX- Sr. Quality Engineer, Devices

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.
The scope of products for which the Sr. Quality Engineer, Devices will be primarily responsible includes contract manufactured and Teleflex-owned suture products/devices for the Mansfield, MA, Coventry, CT, and Nuevo Laredo, MX facilities.

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 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 as applicable.
•    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.

Principal Responsibilities Continued

•    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 based on the problem being solved.
•    Ensure root cause investigations identify systemic causes and result in sustainable corrective and preventive actions rather than documentation-only closure.
•    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.  

 Quality Systems, Compliance & Audit Readiness
•    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. 

Education / Experience Requirements

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

Specialized Skills / Other Requirements

ASQ & Professional Background (Preferred)
•    Experience aligned with ASQ Quality Engineering and Quality Assurance principles.
•    ASQ certifications (CQE, CQA, Six Sigma Green or Black Belt) preferred.
•    Experience applying quality tools with a focus on risk reduction and system effectiveness, not documentation alone.

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The pay range for this position at commencement of employment is expected to be between $127,000- $190,500, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.