Job Overview:
* We are seeking a Quality Engineer 3 to lead all phases of product realization including NPD, NPI, Commercialization, Sustaining, and End of Life.
Responsibilities
As a Quality Engineer 3, you will be responsible for bringing creative, innovative, and sound quality decision-making to the team. You will ensure effective implementation of the required QMS documentation and professional communication with all stakeholders. Key responsibilities include:
* Quality oversight on problems of diverse scope, demonstrating good judgment in selecting methods and techniques for obtaining solutions, driving corrective actions, and verifying effectiveness for assigned area.
* Oversight of QA inspection, testing, and release.
* Guiding, supporting, and training other quality team members.
Key Performance Indicators (KPIs)
The following KPIs will be used to measure your success in this role:
* Compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
* Troubleshooting quality issues identified during product development and commercialization and driving solutions to reduce non-conformances.
* Quality input and guidance on Validation planning and documentation utilizing risk-based decision making and driving risk mitigation activities into process development and product quality assurance.
* Vendor and part appraisal and approval processes.
* Process change and related assessment and implementation of change notification.
* Statistical techniques and visual control systems to monitor manufacturing processes.
Requirements
To be successful in this role, you will need:
* A seasoned, experienced professional with a full working knowledge of EN ISO 13485, the principles of GMP, and FDA QSR 21 CFR Part 820.
* Degree in an engineering/quality or related discipline.
* Certified QE desirable.
* Technical report writing.
* Process validations/FMEA's and protocols.
* Proficient in Statistical analysis.
* Structured Problem-Solving techniques – Lean Six Sigma Green Belt desirable.
* Understanding of Lean Principles.
* Ability to drive projects to completion.
* Guided by the disciplines of due diligence and compliance in all aspects of work.
Benefits
This role offers:
* A dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
* The opportunity to work in a fluid, demanding environment.
* The ability to gain technical understanding of Teleflex processes and products.
* The ability to understand customer/vendor relationships.
* The ability to generate appropriate relationships with customers and vendors.
* The ability to deal with difficult customer or vendor communications.
* The ability to influence customers/vendors where necessary.
* The ability to understand the key drivers of our manufacturing business.
TRAVEL REQUIRED: up to 10%
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