Design Quality Engineer

Hi

My name is Karthik Mutyala from Stark Pharma Solutions Inc we are hiring talents for our client. I am working on Design Quality Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows.

Role: Design Quality Engineer

Location: Warsaw IN & Raynham MA (Onsite)
Duration: 6-Month Contract

Position Overview

We are seeking a Design Quality Engineer to support product development validation and lifecycle management activities within a medical device environment. This role will be responsible for ensuring compliance with design control requirements supporting product validation efforts maintaining Design History File (DHF) documentation and collaborating with cross-functional teams and external suppliers to deliver high-quality compliant products.

Key Responsibilities

• Support product validation (PV) activities including review and approval of validation protocols reports and related deliverables.
• Collaborate with suppliers and contract manufacturers to review technical documentation engineering drawings control plans and validation packages.
• Ensure design and process changes comply with applicable quality system requirements and regulatory standards.
• Participate in risk management activities including FMEA risk assessments hazard analysis and mitigation planning.
• Develop review and maintain Design History File (DHF) documentation to ensure accuracy completeness and regulatory compliance.
• Create and manage traceability matrices linking design inputs outputs verification and validation activities.
• Support design reviews and ensure proper execution of design control processes.
• Partner with R&D Manufacturing Regulatory Affairs and Quality teams throughout the product lifecycle.
• Assist with change control activities ensuring appropriate documentation approvals and implementation.
• Provide support during audits inspections and compliance reviews.

Required Qualifications

• Bachelors degree in Engineering or a related technical discipline.
• 3 years of Quality Engineering experience within the medical device industry.
• Strong knowledge of Design Controls and applicable regulations including FDA 21 CFR Part 820 and ISO 13485.
• Experience supporting Product Validation (PV) activities.
• Experience working with external suppliers contract manufacturers and technical documentation reviews.
• Ability to interpret engineering drawings specifications and control plans.
• Hands-on experience with risk management tools such as FMEA and risk assessments.
• Experience developing and maintaining DHF documentation and traceability matrices.
• Strong technical writing documentation and organizational skills.
• Excellent communication and cross-functional collaboration abilities.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions please send me your updated resume along with the best number and time to reach you.

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Email:

15 Corporate Place S Suite 350

Piscataway New Jersey 08854