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Sr Quality Engineer

4 months ago

Brea, United States Ursus Inc Full time

Quality is in Our Blood.

Innovation and safety are at the core of what we do. Our products and devices target early diagnosis and treatment of patients across a wide range of indications, with more products in several stages of clinical development. We have a need for talented Quality Assurance Engineers to join our established team of professionals. Uniquely, this role offers hands-on technical mentorship and guidance from a Quality perspective during all stages of device development. We're looking for Quality Engineers looking to grow their skills, with an eye on those with leadership abilities for long-term career growth.

This growing team is looking for someone to start work quickly. Is that you?

Responsibilities:

Leads quality assurance activities throughout the product lifecycle, from design quality to manufacturing and post-market

Assesses and mitigates quality risks associated with product design, review DHF documentation, evaluate component risk, and identify critical features

Develops and implements quality plans and inspection procedures, and test methods

Evaluates and qualifies client suppliers, evaluate manufacturing processes and supplier operations

Conducts and leads quality audits to ISO 13485 standards, ensuring compliance and identifying areas for improvement

Collaborates closely with cross-functional teams including internal and client team members throughout the development process

Investigates non-conformances, root causes, and corrective/preventive actions to drive process improvements and prevent recurrence.

Provides guidance and support to internal stakeholders on quality-related issues, ensuring adherence to regulatory requirements and industry best practices.

Qualifications:

Bachelor's degree in engineering or related field.

Minimum of 8 years of experience in quality engineering role(s) within the medical device industry.

In-depth knowledge of quality management systems, regulatory requirements, and standards, including ISO 13485.

Proven experience in conducting ISO 13485 quality audits and implementing corrective/preventive actions.

Strong understanding of design control processes, manufacturing processes, and supplier management.

Proficiency in risk management methodologies.

Excellent analytical and problem-solving skills, with a keen attention to detail.

Effective communication and interpersonal skills, with the ability to collaborate across teams and with clients and suppliers.

Demonstrated ability to work independently and make sound decisions in a fast-paced environment.

Bonus Points for:

Master's degree in biomedical engineering

Experience working for large medical device manufacturers

Why Choose Us?

We're committed to excellence, and focus on building innovative products for our patients and healthcare providers. We believe that every voice on our team matters.

We want to change the future, and we need you to do it. Apply Now

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