Quality Engineer

Top Job

Located in Laguna Hills, CA

Salary: $80K+

Express Employment Professionals is actively looking for A Quality Engineer for a great Medical Device company in Aliso Viejo.

 

SUMMARY:

Our R&D team seeks an experienced Quality Assurance Engineer responsible for medical device quality.

The QA Engineer works closely with engineering and quality assurance to ensure that our medical device solutions meet relevant safety, quality, and regulatory standards. As the quality and regulatory subject matter expert of our small team you will both execute and lead. You will establish processes and implement creative solutions where clear guidelines may not exist. Drawing from design control experience, you will develop and maintain detailed documentation and records throughout all phases of product development in adherence with quality and regulatory requirements.

 

RESPONSIBILITIES:

· Understand and apply the design and change controls processes to medical device projects and subprojects.

· Establish product development plans; perform risk analysis in accordance to ISO 14971 and develop mitigation strategies.

· Influence product requirements to ensure that reliability, quality, regulatory, and safety needs are met and that design specifications are clear, traceable, and testable.

· Lead and support design verification and validation (V&V) and process validation for medical device projects, including statistical rationale for testing, and oversee test execution.

· Draft, review and edit project documentation for compliance.

· Maintain design history files (DHF) to be organized, complete, traceable, auditable, and supportive of regulatory product registration needs.

· Work alongside our engineering team and company management to resolve issues related to usability, requirements, hardware specifics, scope, timelines, and resources.

· Write, review, update, and maintain process documentation (SOPs, work instructions, forms, etc.), and provide training on these processes.

· Define and implement product quality improvement initiatives.

· Write, review, update, and maintain regulatory/compliance processes, concepts, and best practices.

· Author and manage Corrective Action Preventive Action (CAPA) and Nonconformance Event Management (NER) reports.

· Perform additional duties as assigned.

 

SKILLS and ABILITIES:

·A minimum of 4 years of experience in the regulated medical device industry as a Quality Assurance Engineer supporting new product development is preferred.

·Strong working knowledge of applicable regulations and standards to medical devices IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 13485, ISO 14971, FDA including 21 CFR 11 and EU MDR)

· Highly proficient in MS Word, Excel, and PowerPoint

· Ability to articulate complex technical problems and business value to a wide audience.

· Ability to summarize technical information to a variety of functions.

· Detail focused with excellent communication and documentation skills.

 

EDUCATION:

Bachelor’s degree or higher in Biomedical Engineering , Mechanical Engineering, Electrical Engineering, or a related field or equivalent project experience. (Master’s degree may be equal to 2 years of working experience.)

 

TRAVEL:
Must be willing and legally able to travel internationally as needed to meet company needs.

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