Senior Medical Device Quality Assurance Engineer
hace 3 semanas
Company Overview
Baxter is a leading medical technology company dedicated to improving patient outcomes through innovative products and therapies.
We are committed to providing quality healthcare solutions that transform lives.
Job Summary
This role involves ensuring the highest quality and product safety in medical device projects, working closely with R&D teams at our Monterrey, Mexico site.
Main Responsibilities
- Participate in Design Assurance improvement initiatives to enhance the overall quality of new product designs and regulatory compliance profile.
- Prepare, manage, and update Design Assurance required sustaining engineering deliverables.
- Ensure product development activities related to verification and validation comply with quality system procedures.
- Identify and mitigate product or process-related risks.
- Support CAPA and FA processes by performing investigations, root cause analyses, and verification of effectiveness checks for design-related issues impacting the field.
Requirements
- B.S. in Engineering, preferably Mechanical, Electrical, Electronics, or Computer Engineering.
- 5+ years' experience in medical device or regulated technical industries (e.g., aerospace, automotive, defense) in a design/development/quality role desired.
- Product Design experience may be considered in lieu of Quality Assurance experience.
- Knowledge of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards.
- Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable.
- Knowledge of EN ISO 14971:2012; safety by design; Risk Management structure desirable.
- Ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills.
Estimated Salary Range
$120,000 - $180,000 per annum, depending on location and experience.
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