Sr. Design Quality Engineer

2 days ago

Ponte Vedra, United States Treace Full time
Company Description

Be a part of something amazing

We are on a mission to advance the standard of care for the surgical management of bunion deformities and related midfoot correction. We intend to exceed our customers' expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, we assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders and doing it all with the highest standards of ethical conduct.

With focus on one world class procedure with patented products, you will have the capability to advance your career while collaborating with a diverse team of talented individuals.

So, if you are looking to build something greater than yourself and work alongside some of the most dynamic and talented people in the industry, Treace may be the right place for you.

Our Core Values and Beliefs

We believe a strong culture of integrity and compliance is critically important to building a world class business. Our shared values support our commitment to this philosophy.
  • Advancing medical learning is at our core.
  • Create true value - not through paper or gimmicks.
  • Have a sense of urgency to win every day.
  • Only surround yourself with high performers.
  • Always do the right thing for our customers, employees, and shareholders.
  • Have a passion for your job and enlist the willing cooperation of others.
  • No surprises - tell the bad news first, not last.
  • Maintain an employee-friendly environment.
  • Have fun with your job

Lapiplasty Video

Job Description

POSITION SUMMARY:

The Sr. Design Quality Engineer (SDQE) is accountable for supporting new product development and provides quality oversight to the Research & Development (R&D) organization while working within a multi-functional team environment for medical devices. The SDQE will handle projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements. The SDQE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement.

PRIMARY DUTIES & RESPONSIBILITIES:

• Support concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user)
• Responsible for creating and maintaining product and process risk management files to meet FDA and ISO standards.
• Leads device material qualification activities and product transfer activities to current and new suppliers.
• Responsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product.
• Provide Quality oversight and approval of qualification/validation/design controls activities.
• Liaison with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented.
• Leads root cause investigations and coordinates timely action implementation with the CAPA process.
• Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
• Evaluates product changes and directs appropriate disposition of product through the company's change control system.
• Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications.
• Participates in hands on cadaver labs, quality system audits (FDA, ISO, Internal, etc.) Kaizens, and Rapid Improvement Events

Qualifications

• Bachelor's degree in Engineering, Science, Technology or a related discipline
• 5+ of progressive medical device engineering experience in Manufacturing, Development, or Quality Engineering
• Familiarity working within an FDA compliant Title 21 section 820 environment.
• Certified Quality Engineer preferred.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace's policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

Treace is a drug free employer.

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