Date Posted: December 18, 2017
Job Type: Direct Hire
Job ID: 292772
Quality Assurance Engineer
Our Client is engaged in seeking a Quality Assurance Engineer in Miami, FL.
The Quality Assurance Engineer represents Quality Engineering within the New Product Development team supporting the activities during various stages of a product’s life cycle. This individual ensures that either new product development or sustaining engineering projects are conducted in compliance with internal, customer, and regulatory requirements.
This individual will work in a design team setting. This individual will support design control activities for new product development efforts, including design transfer. He/she will develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans. The Quality Assurance Engineer will provide leadership in the understanding of medical device regulations to other disciplines. He/she must be able to communicate effectively at all levels within Quality as well as across other departments such as R&D, Regulatory, Manufacturing, and Marketing.
The Quality Assurance Engineer participates in component and service supplier evaluation, including supplier audits, if applicable. This individual works with suppliers to ensure appropriate quality controls are implemented. The individual in this position will be expected to review lot documentation and release product for clinical use, as well as taking leadership of Design History Files. This individual guides product development teams on efficient and effective application of design controls.
• A minimum of a Bachelor Degree in an Engineering or Scientific discipline.
• A minimum of 4 (work, internship, co-op, etc.) years’ experience in a GMP and/or ISO regulated industry.
• Medical Device industry experience.
• Quality engineering experience within a design and development environment.
• Experience with Blueprint reading/literacy.
• Familiarity with inspection methods and sampling techniques as well.
• Excellent problem solving and decision-making skills will be required.
• Interpersonal skills that foster conflict resolution as it relates to technical situations.
• Mechanical product knowledge.
• Knowledge of ISO 14971.
• Experience conducting Process/Design Failure Mode Effects and Analysis.
• Proficiency in test method validation.
• Process Excellence/Lean experience.
About Our Client:
Our Client works with an extensive network of engineers, surgeons and hospitals as well as leaders in the medical device industry worldwide. We are a small, effective company that promotes a challenging work environment in a team building and problem-solving atmosphere. Our team takes products from the initial concept stage through the phases of designing, prototyping, testing and commercialization. They focus on the development of innovative technologies for medical devices that will not only meet the needs of the patients, but also improve their quality of life.