Quality Assurance Engineer

BVI Medical

Ciudad Juárez

On-site

MXN 925,583 - 1,295,816

Full time

14 days+

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Job summary

A medical device manufacturer in Ciudad Juárez is seeking a Quality Engineer to analyze complaint data and ensure compliance with various quality standards. The ideal candidate will have 3-5 years of experience in the medical device industry and a strong technical background with a BA/BS degree. Responsibilities include developing corrective action plans and leading quality improvement initiatives. This full-time position offers opportunities for professional growth in a vital area of healthcare.

Qualifications

3-5 years of experience as a Quality Engineer in the medical device industry.
Experience with CAPA, complaint investigation, and risk management.
CQE or CQA certification preferred.

Responsibilities

Review and analyze complaint data.
Perform root-cause investigations and develop corrective action plans.
Ensure compliance with FDA QSR and ISO 13485.

Skills

Statistical analysis

Organizational skills

Time management

Quality system knowledge

Communication skills

Education

BA/BS degree in science or technical field

Job description

Direct message the job poster from BVI Medical

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

Education & Business Experience Requirements

Minimum 3 to 5 years’ experience as a Quality Engineer in the medical device industry
BA/BS degree in science or other technical field.
Experience in starting and transferring operations abroad to Mexico.
Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
Demonstrated skills in statistical analysis.
Individual must have a hands-on approach.
Experience participating in internal and external audits (e.g., FDA, Suppliers)
Strong organizational and time management skills.
Experience with CAPA, complaint investigation, field action processes and risk management.
CQE, CQA preferred

Required Competencies

Recognized as a technical leader within the company and engenders trust when working with customers or suppliers
Capable of leading a Continuous Improvement Team, CAPA team, or working with a customer or supplier to resolve product quality issues
Works effectively on cross functional teams to establish appropriate processes pertaining to quality Communication
Excellent written and oral communication skills
Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations

Description of Responsibilities

The Quality Engineer is responsible for reviewing and analyzing complaint data, performing root-cause investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485, Canadian Medical Device Regulations (EU MDR), and the Medical Devices Directive (MDD).

Seniority level