Company Description
Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. 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, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.
Job Description
POSITION SUMMARY:
The Design Quality Engineer (DQE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives. The DQE 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 AND RESPONSIBILITIES:
- Conducts detailed root cause investigations and coordinates timely action implementation with the CAPA process
- Evaluates product changes and directs appropriate disposition of product through the company’s change control system
- Responsible for maintaining calibration status of gaging and assessing results of calibration activities
- Responsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product
- Support concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user)
- Participate in hands on cadaver labs
- Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications
- Interfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented
- Participates in Kaizens, Rapid Improvement Events, and Continuous Improvement programs
Qualifications
MINIMUM REQUIREMENTS:
Education and Experience: Bachelor's degree in Engineering, Science, Technology or a related discipline with 3+ years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant Title 21 section 820 environment
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.
