Quality Engineer, NPD

Locations:
Ft. Lauderdale, FL

Applicants: Click here to apply
 


Job Description:

Will partner with a cross functional design team that develops new products for the orthopedic market. The appropriate candidate will complete quality deliverables throughout the phases of development as defined in the project plan, specifically hazard and risk analysis documents and verification / validation testing plans, protocols, and reports. Will provide guidance to the team in order to ensure compliance to the company's quality systems and other relevant standards while enabling speed to market and attainment of team goals. The design team will look to this person for input and direction regarding quality engineering, quality assurance and quality control aspects of the project.

Responsibilities:

• Develops Quality Assurance Plans for new products.
• Participate in design reviews by identifying design weaknesses and risks associated with the product use and tracking the mitigation of those issues throughout the development process.
• Manage the hazard and risk analysis processes, including direct responsibility for tangible outputs.
• Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria. Promote efficient testing practices.
• Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary.
• Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
• Identify supplier assessment requirements and communicate these to the supplier quality group.
• Support quality system maintenance primarily for the design control process by identifying and correcting deficiencies in our procedures and practices.
• Lead CAPA teams in the analysis and resolution of product quality issues.
• Develop quality assurance documentation to support regulatory submissions.
• Evaluate product design changes for verification and validation requirements and assist in change implementation.
 

• Bachelor's degree with at least 2 years experience of quality engineering experience in New Product Development, or combination of education and experience required.
• Knowledge of QSR and / or ISO 13485 Design Control procedures is required.
• Knowledge of ISO 14971 and implementation of this standard.
• Ability to read and interpret CAD (e.g. Solidworks) drawings is required.
• Strong technical written, verbal, analytical and interpersonal skills. Self-motivated. Strong time management and organizational skills.
• Strong statistical skills (e.g. ANOVA, distribution analysis, DOE, significance tests, process capability, sampling plans, regression, GR&R, etc.).
• Demonstrated experience using Microsoft Office products, Outlook and Minitab.
• American Society for Quality, Certified Quality Engineer (CQE) preferred.
• Training or certification in Six Sigma and Lean Methods is a plus