Fluent in English (spoken and written)., Diploma in engineering or a related quality discipline, with relevant experience in a regulated industry., 3 years' experience in a Quality Assurance role, preferably in the medical devices industry., ISO 13485 trained auditor with knowledge of medical device regulations..
Key responsabilities:
Qualify and evaluate new and existing suppliers, coordinating performance monitoring and agreements.
Coordinate CAPAs, NCRs, and SCARs, including root cause analysis and risk assessments.
Lead supplier audits and develop quality improvement plans as necessary.
Liaise with cross-functional teams to implement quality improvements and prepare summary reports for management reviews.
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BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs.
We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
As a Global Supplier Quality Engineer, you will work autonomously to manage supplier interactions worldwide, ensuring compliance and continuous improvement through evaluation, approval, monitoring, and feedback. You will build strong relationships to foster collaboration and effective supplier management while liaising across multiple sites and functions to investigate and resolve quality issues as they arise.
Key Responsibilities
Qualify new suppliers and continuously evaluate and maintain existing critical suppliers with cross-functional support, coordinating supplier surveys, agreements, and performance monitoring.
Coordinate activities related to CAPAs, NCRs, and SCARs, including conducting root cause analysis, investigations, responses, and risk assessments.
Facilitate the assessment of supplier-notified changes and manage the communication of internal changes to relevant suppliers.
Lead supplier audits and develop, agree upon, and track quality improvement plans as necessary.
Proactively review supplier risks and develop strategies for part and process quality improvements.
Liaise with production, quality, supplier, and technical personnel across multiple sites to identify and implement quality improvements.
Prepare summary reports and participate in management review and other formal review meetings.
Support internal and external quality audits, including customer audits.
Produce quality specifications, purchasing specifications, and procedures to ensure consistent implementation.
Adhere to the company’s health, safety, environmental, and quality policies and systems.
Stay up to date with industry trends and best practices, proactively identifying opportunities for continuous improvement.
Qualification
Fluent in English (spoken and written).
Diploma in engineering or a related quality discipline, and/or relevant experience gained within a regulated industry or similar manufacturing environment.
3 years' experience in a Quality Assurance role, preferably within the medical devices industry.
ISO 13485 trained auditor.
Knowledge of medical device regulations, including FDA, ISO 13485, MDD, and EU MDR.
Proficient in Microsoft Office (Excel, Word, PowerPoint).
Strong root cause analysis skills.
Company
BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
Required profile
Experience
Spoken language(s):
English
Check out the description to know which languages are mandatory.