Job Description
We are seeking a highly skilled Quality Engineer to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the quality system meets international standards.
The successful candidate will be responsible for implementing and maintaining quality systems according to ISO 13485, ISO 9001, and relevant medical device regulations.
This position involves carrying out internal audits to the ISO 13485 standard, participating in customer and regulatory audits, supporting product development, production trials, and sampling.
You will also be responsible for maintaining vendor relationships, identifying problem vendors, reporting quality performance data, driving continuous improvement processes, managing investigation and closure of validation deviations, non-conformances, and CAPAs.
A bachelor's degree in science, engineering, or a related field is required, along with at least three years' experience working at quality engineer level in an ISO 13485 regulated environment.
Required Skills and Qualifications
* Bachelor's degree in science, engineering, or a related field.
* At least three years' experience working at quality engineer level in an ISO 13485 regulated environment.
* Internal auditor qualifications to ISO 13485.
* Experience with equipment validation and statistical analysis.
Benefits
This role offers a challenging and rewarding career opportunity for a motivated and experienced quality professional.
You will have the opportunity to work on a variety of projects, develop your skills and expertise, and contribute to the success of our organization.
What We Offer
We offer a competitive salary and benefits package, including health insurance, retirement savings plan, and paid time off.
We are committed to providing a safe and healthy work environment, and we are proud to be an equal opportunities employer.
We are looking for a talented and dedicated individual who shares our values and is passionate about delivering high-quality results.