Lead Quality Assurance and Regulatory Assurance

This QA/RA role is responsible for supporting R&D project teams through the New Product Development process for various medical devices.his position will also be responsible for participating on various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company’s regulatory compliance profile.
Essential Duties and Responsibilities:
Responsible for all QA/RA functions as a core team member on new product development (NPD) teams
Prepares and manages all QA/RA required NPD deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements
Monitors the Design Controls portion of the quality system for compliance with regulatory and system requirements
Responsible for ensuring compliance to product verification and validation regulations
Facilitates and completes root cause analysis investigations when design challenges are encountered
Ensures important design characteristics are properly identified for correct level of controls
Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEA’s, etc.
Facilitate and support various reviews throughout the project to include Product Safety Committee, Phased Gate Design Reviews and Post Launch Analysis
Actively participate and/or lead Design History File audits and follow-on remediation efforts as required
Provides training to ensure proper implementation and use of quality tools and procedures as required
Enables rapid and effective correction of quality/regulatory problems in a manner that prevents reoccurrence
Participates on various continuous improvement/process improvement teams
Proficient with Quality System Regulations, Medical Device Directive, and ISO Quality System Standards
Demonstrated ability to work and perform in team environments
Excellent analytical decision-making and problem-solving skills
Proven ability to resolve issues and participate in process improvement activities
Track record of successful business and customer orientation


Education and/or Experience:
3+ years of Quality/Regulatory experience required
B.S. in Engineering or other 4 years Bachelor’s Degree required
Experience in a medical device company / industry required
Experience in New Product Development/Design Controls required
Experience with 510(k) preparation and submission desired

MassChallenge Boston 2016 Accelerator
Job Type:
A full-time permanent position
Application Email:
Coeo Labs Private Limited