Quality Engineer III, Design Assurance

As a member of a cross-functional team, the Quality Engineer III, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. The Quality Engineer III, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer III, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.

What You Will Do

Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design. Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports to assess the risks associated with a product. Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it's current risk profile.

Why It Might Be a Fit

The Quality Engineer III, Design Assurance will be a fit for someone with a strong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. The ideal candidate will be proficient in MS Office, and Minitab or other statistical software, and have strong organizational and time management skills to meet deadlines while managing multiple projects.

Requirements

• B.A. or B.S. degree in a technical discipline, such as engineering or science
• Minimum 5 to 10 years of quality engineering or design assurance experience
• ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB)
• Strong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820
• Proficient in MS Office, and Minitab or other statistical software
• Strong organizational and time management skills to meet deadlines while managing multiple projects

Benefits

• Medical, prescription drug, dental and vision insurance
• Flexible spending accounts
• Participation in 401(k) savings plan
• Paid time off benefits, such as PTO, short- and long-term disability and parental leave