Sr. Design Quality Engineer

Sr. Design Quality Engineer

Job Description:

Join us in our mission to elevate the standards of care in the surgical treatment of bunion deformities and related midfoot corrections. We are committed to exceeding our customers’ expectations through innovative solutions and a rapid, high-velocity approach to addressing surgical challenges. In this role, you will play a pivotal part in guiding the quality processes throughout the product development lifecycle, ensuring that our medical devices are designed and manufactured to the highest quality standards. You will collaborate with a diverse and talented team to not only enhance patient outcomes but also contribute to reducing healthcare costs, all while maintaining ethical integrity in our practices. This position offers the opportunity to grow your career in a supportive environment focused on one world-class procedure with patented products. Be part of a team that values integrity, compliance, and innovation, and where you can truly make a difference in the medical field.

IT Languages:

• FDA regulations
• ISO standards
• Risk management methodologies

As a Senior Design Quality Engineer, you will be responsible for a variety of critical tasks to ensure product quality and compliance throughout the development process.:

Engage in concurrent engineering efforts as a quality assurance representative on product development teams, ensuring both supplier and end-user perspectives are considered.;; Develop and maintain comprehensive product and process risk management files that conform to FDA and ISO standards.;; Lead material qualification activities and manage product transfer processes with both current and new suppliers.;; Create inspection models, prints, and detailed testing requirements to guarantee the delivery of high-quality products.;; Oversee qualification, validation, and design control activities, ensuring alignment with quality standards.;; Act as a liaison with supplier quality representatives to address quality assurance issues and implement corrective actions effectively.;; Conduct root cause investigations and coordinate with the CAPA process to ensure timely resolution of quality issues.;; Revise and update quality system procedures in collaboration with cross-functional teams to ensure best practices are followed.;; Evaluate product changes and manage their disposition through the company's change control system.;; Review non-conformance reports and recommend modifications to inspection processes, product design, or quality systems.;; Participate in hands-on cadaver labs, quality system audits, and continuous improvement events.

Spoken Languages:

• English

Skillset:

• Quality assurance
• Risk management
• Material qualification
• Design control
• CAPA process

Soft Skills:

• Attention to detail
• Strong communication skills
• Problem-solving abilities
• Team collaboration
• Adaptability

Qualifications:

• Bachelor's degree in Engineering, Science, Technology or a related discipline
• 5+ years of progressive experience in medical device engineering, particularly in Manufacturing, Development, or Quality Engineering
• Experience in an FDA compliant environment under Title 21 section 820
• Certified Quality Engineer preferred, but not mandatory

Years of Experience:

5

Location:

Ponte Vedra Beach, FL, United States

Job Benefits:

• Competitive salary
• Health and wellness programs
• Professional development opportunities
• Flexible work hours
• Collaborative work environment

Working Conditions:

Full Time

Employment Type:

Permanent Contract

Company Culture:

• We foster a culture of integrity, collaboration, and innovation. Our team thrives on high performance, taking initiative, and maintaining a fun, employee-friendly environment. We are committed to doing the right thing for our customers, employees, and shareholders, and we believe that advancing medical learning and creating true value is at the heart of our mission.

Opportunities For Advancement:

• Career growth within the organization, Exposure to cutting-edge technologies, Leadership development programs

Visa Sponsorship:

Not Available