Quality Engineer 1

About Teleflex

Teleflex Incorporated is a global medical technology company committed to enhancing health and quality of life. Our diverse product portfolio spans anesthesia, emergency medicine, interventional cardiology and radiology, surgery, vascular access, and urology. Our trusted brands include Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™, and Weck™. Visit teleflex.com for more details.

Teleflex Medical OEM delivers comprehensive product development and manufacturing services, specializing in extrusions, catheters, sutures, and bioabsorbable materials. Our in-house expertise covers engineering, regulatory, prototyping, manufacturing, assembly, and packaging.

Position Summary

The Quality Engineer 1 will support manufacturing quality by ensuring sound decision-making, compliance with quality management systems (QMS), and effective communication with stakeholders. Responsibilities include tackling quality challenges ranging from complaint investigations to non-conformance resolution, supporting product release, and training team members. The role spans the entire product lifecycle from new product introduction to end of life.

Key Responsibilities

• Provide quality support to project teams, ensuring customer and QMS compliance with GMP standards.
• Review and align product specifications with customer requirements and internal capabilities to minimize variation.
• Troubleshoot quality issues using structured problem-solving and manage non-conformance cases from initiation through closure.
• Oversee testing and release of products, including disposition of non-conforming materials with appropriate documentation.
• Act as key responder to customer quality feedback and requests.
• Guide validation planning and documentation through risk-based decisions (pFMEA) and risk mitigation activities.
• Review and control process changes and assist with change notifications.
• Participate as QA representative in statistical technique implementation and visual process monitoring systems.
• Create, execute, and review inspection plans, test methods, validations, deviations, and related documentation for regulatory compliance.
• Ensure adherence to quality plans and specifications throughout product development and commercialization phases.
• Monitor process quality performance and initiate improvement actions as required.
• Review and approve QMS documentation and records.
• Lead or contribute to cross-functional teams focused on waste elimination and performance enhancement.
• Support compliance programs, internal audits, customer audits, and regulatory inspections.
• Ensure adherence to Quality and Environmental Health & Safety policies.
• Provide quality input for vendor and part appraisal and approval processes.

Required Qualifications and Experience

• Proven knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820, and GMP principles.
• Degree in engineering, quality, or related fields.
• Certified Quality Engineer credential preferred.
• Strong technical report writing abilities.
• Experience with process validations, FMEAs, and protocol development.
• Understanding of statistical analysis methods.
• Familiarity with structured problem-solving techniques; Lean Six Sigma Green Belt is desirable.
• Knowledge of Lean manufacturing principles.
• Demonstrated ability to drive projects to completion with due diligence and compliance focus.

Additional Skills and Attributes

• Excellent written and verbal communication skills.
• Meeting leadership and teamwork capabilities.
• Self-motivated with minimal supervision needed.
• Insight into key manufacturing business drivers and cross-departmental impacts.
• Strong customer and vendor relationship management, including handling difficult communications and influencing stakeholders.

Additional Information

No travel is expected. Teleflex is an equal opportunity employer welcoming applications regardless of age, gender, race, disability, religion, or sexual orientation. We foster a diverse and inclusive culture where every employee can thrive.

We conduct a thorough hiring process without unsolicited offers or fees.