Sr. Quality Design & Development Engineer

About This Role

This role is a Senior Quality Design & Development Engineer position focused on ensuring quality throughout product development and manufacturing processes for complex medical devices. The role involves managing design control, regulatory compliance, and supporting quality system strategies.

Responsibilities

• Develop and perform operational and process qualifications for customer manufacturing processes
• Assist with the development/update of FMEA and Hazard Analysis
• Generate the Quality Plan for development projects
• Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans
• Create appropriate sampling plans along with identifying inspection and acceptance criteria
• Review and/or document Design Control activities for Project Phase Reviews and Product Verification testing
• Perform vendor audits and qualifications
• Represent quality engineering in phase reviews and other aspects throughout product development
• Manage the internal audit system schedule and perform duties of a Lead Auditor
• Perform internal audits to assess compliance to FDA and ISO 13485 requirements

Requirements

• Bachelor’s degree in a STEM Engineering field
• 5+ years of experience in Quality Engineering
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes
• Extensive experience with medical device QSRs in design control and production environments
• Strong familiarity with Class II or Class III medical devices requirements
• Knowledge of FDA/cGMP and MDD regulations/guidelines
• Experienced with ISO13485
• Fluent in use of computer systems for the analysis of data, specifically Microsoft Office
• Excellent verbal communication, organizational, and management skills
• Strong verbal and written communication skills including technical report writing
• Ability to work with R&D, Manufacturing, and QA, accomplishing results with minimal guidance
• Must be able to read, write, and speak fluent English
• Demonstrated use of Quality tools/methodologies including Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R

Qualifications

• Bachelor’s degree in a STEM Engineering field
• 5+ years of experience in Quality Engineering

Nice to Have

• CQE certification

Skills

* Required skills

Benefits

Certifications