What are the responsibilities and job description for the Design Quality Engineer - Medical/pharma position at Intellectt Inc?
Job Title: Design Quality Engineer
Location: Marlborough, MA
Work Type: Long term Contract
Pay Rate: $45 - $50/hr W2 – Depends on the experience
Job Summary
We are seeking an experienced Design Quality Engineer to support product development and design control activities for medical devices. The ideal candidate will work closely with Research & Development (R&D), Regulatory Affairs, Manufacturing, and cross-functional engineering teams to ensure products meet applicable quality standards, regulatory requirements, and customer expectations throughout the product lifecycle.
Key Responsibilities
Support design control activities in accordance with FDA 21 CFR Part 820, including applicable Quality Management System Regulation (QMSR) requirements.
Ensure compliance with ISO 13485 and applicable medical device regulations.
Review and approve design and development plans, design inputs, design outputs, design reviews, verification, and validation documentation.
Participate in Design Failure Mode and Effects Analysis (DFMEA), Process FMEA, risk assessments, and risk management activities in accordance with ISO 14971.
Support design verification and validation (V&V) activities, including protocol and report reviews.
Ensure traceability between user needs, design inputs, design outputs, verification, and validation requirements.
Review engineering changes, product specifications, drawings, and technical documentation.
Support nonconformance investigations, root cause analysis, CAPA, and corrective and preventive actions.
Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams to resolve quality issues.
Participate in design reviews, risk reviews, audits, and continuous improvement initiatives.
Maintain design history files (DHF), device master records (DMR), and other quality documentation, as applicable.
Support process improvements and ensure adherence to established quality procedures.
The ideal candidate is detail-oriented, understands medical device quality regulations, and can partner with engineering teams to ensure design quality, patient safety, product reliability, and regulatory compliance throughout the product development lifecycle.
Benefits:
Eligible employees may enroll in and receive benefits offered by Intellectt Inc., subject to applicable plan terms, eligibility criteria, and contribution requirements.
Equal Employment Opportunity
Intellectt Inc. is an Equal Employment Opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees. Employment decisions are based on job-related qualifications, skills, experience, and business needs, consistent with applicable federal, state, and local laws.
We value diversity and inclusion and encourage all qualified individuals to apply. If you require a reasonable accommodation during the application or hiring process, please contact us to discuss your needs.
Regards,
Karthik Mulka
Lead - TA
Phone: 908-905-2354
Email: karthik.m@intellectt.com
Salary : $45 - $50