Quality Engineer

Quality Engineer

My client is a trailblazer in the medical device sector, celebrated for its groundbreaking innovations in circulatory system technologies. The company has garnered widespread acclaim for its commitment to excellence, consistently delivering high-quality solutions that advance the diagnosis and treatment of vascular conditions. With a stellar reputation for adherence to stringent quality standards, including FDA regulations and ISO 13485 compliance, my client sets a gold standard in the industry. The organization fosters a culture of innovation and collaboration, empowering its dedicated team to drive advancements in medical technology. Recognized for its positive impact on patient outcomes, they stand as a beacon of success, dedicated to pushing the boundaries of what is achievable in the realm of healthcare.

Job Description

Ensure compliance: Monitor and uphold adherence to FDA regulations and ISO 13485 standards in all aspects of the medical device manufacturing processes.

Quality Assurance: Develop, implement, and maintain quality assurance procedures to guarantee the consistent production of high-quality vascular technologies.

Process Improvement: Identify opportunities for process improvements and work collaboratively to implement changes that enhance efficiency and reduce defects.

Risk Management: Utilize expertise to assess and mitigate risks associated with product quality, regulatory compliance, and overall manufacturing processes.

Root Cause Analysis: Investigate and analyze non-conformities and product defects, conducting thorough root cause analyses to implement corrective and preventive actions.

Documentation Control: Oversee the maintenance and control of quality-related documentation, ensuring accuracy and compliance with industry standards.

Validation: Lead and support validation activities, including process validation, equipment qualification, and software validation as required.

Statistical Analysis: Apply statistical tools and methodologies to assess and improve product and process capabilities, ensuring data-driven decision-making.

Cross-functional Collaboration: Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure seamless integration of quality requirements throughout the product lifecycle.

Training and Education: Provide training and support to personnel on quality-related matters, fostering a culture of continuous improvement and quality awareness within the organization.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Educational Background: B.S. degree in engineering

Experience: 1-3 years of experience in quality, R&D or design engineering within the medical device industry

Regulatory Knowledge: Demonstrate in-depth knowledge of FDA regulations and experience with ISO 13485 compliance, ensuring a thorough understanding of the regulatory landscape.

Analytical Skills: Exhibit strong analytical abilities to identify, assess, and resolve complex quality issues, contributing to continuous improvement initiatives.

Problem-Solving: Showcase effective problem-solving skills, particularly in conducting root cause analyses and implementing corrective and preventive actions.

Process Improvement: Display a proactive approach to process improvement, with a history of successfully implementing changes that enhance efficiency and product quality.

Validation Experience: Have experience leading and supporting validation activities, including process validation, equipment qualification, and software validation.

Statistical Analysis: Familiarity with statistical tools and methodologies, showcasing the ability to analyze data and make informed decisions to enhance product and process capabilities.

Communication Skills: Exhibit excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams and the ability to convey complex quality concepts clearly.

What's on Offer

Competitive Salary

Healthcare Benefits

Retirement Plans

Professional Development

Flexible Work Arrangements

Cross Collaboration for Candidate