Job Overview:
We are seeking a seasoned Quality Engineer to drive large-scale remediation in the medical device industry.
This contract role offers an opportunity to work on production line processes, ensuring compliance and efficiency across various products.
You will collaborate with cross-functional teams in Manufacturing and Quality Engineering, receiving clear direction and support to drive remediation deliverables forward.
Key Responsibilities include:
* Reviewing, assessing, and updating manufacturing processes with a focus on risk assessment and process validation.
* Writing, reviewing, and approving validation protocols and reports.
* Updating and reviewing manufacturing instructions and MES documents.
* Supporting Device Master Record remediation activities and owning NC/CAPA actions as needed.
Requirements:
A strong background in quality assurance and regulatory compliance is essential for this position. Experience in medical device manufacturing or quality is also required. In addition, hands-on experience supporting manufacturing lines in regulated environments is necessary.
The ideal candidate will possess excellent analytical skills, attention to detail, and effective communication skills. A degree in a relevant field such as engineering, science, or technology is preferred but not required.
In this role, you will have the opportunity to develop your skills and expertise while contributing to the success of our organization. We offer a dynamic and supportive work environment that fosters growth and development.
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What We Offer:
We provide competitive compensation packages, including salary, benefits, and opportunities for professional growth and development. Our company values diversity, equity, and inclusion and strives to create a workplace that is welcoming and inclusive to all employees.
We encourage applicants from diverse backgrounds to apply. If you are a motivated and experienced Quality Engineer looking for a new challenge, please submit your application.