Design Quality Engineer

Stark Pharma Solutions Inc; Warszawa; On-site; PLN 327,000 - 462,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking a Design Quality Engineer to support product development, validation, and lifecycle management within a medical device setting. You will ensure design control compliance, maintain the DHF, and collaborate with suppliers to deliver compliant products.

The role requires 3+ years in quality engineering for medical devices, strong regulatory knowledge, and hands-on risk management.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 3+ years of Quality Engineering experience in medical devices.
• Strong knowledge of Design Controls and regulations (FDA 21 CFR Part 820, ISO 13485).
• Experience supporting Product Validation activities.
• Experience with external suppliers and technical document reviews.
• Ability to read engineering drawings, specifications and control plans.
• Hands-on risk management (FMEA, risk assessments).
• Experience maintaining DHF documentation and traceability matrices.

Responsibilities

• Support product validation activities, including review/approval of protocols and reports.
• Collaborate with suppliers and contract manufacturers on documentation and validation packages.
• Ensure changes comply with quality systems and regulatory standards.
• Participate in risk management activities and mitigation planning.
• Develop and maintain DHF documentation for regulatory compliance.
• Create and manage traceability matrices linking design inputs/outputs.
• Support design reviews and proper design control execution.
• Partner with R&D, Manufacturing, Regulatory Affairs and Quality teams.
• Assist with change control and documentation approvals.
• Provide support during audits and inspections.

Skills

Quality engineering

Design controls

Regulatory knowledge

Cross-functional collaboration

Technical writing

Risk management

FMEA

Education

Bachelor's degree in Engineering

Job description

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. 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

• Bachelor s 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.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: [e-mail]

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com