Senior Quality Engineer - Drug-Coated Medical Devices

Stark Pharma; Arden Hills (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Stark Pharma is seeking a Senior Quality Engineer in Arden Hills, MN to enhance processes and ensure quality in drug-coated medical devices. The role requires expertise in quality systems, process validation, and compliance with FDA regulations. Ideal candidates will have 6-8+ years of experience in medical devices and solid understanding of industry standards. Responsibilities include reviewing change requests, maintaining quality documentation, and leading inspection activities.

Qualifications

• 6-8+ years of experience in Quality or Design Quality Engineering within medical devices.
• Hands-on experience with combination products (drug-coated devices strongly preferred).
• Strong knowledge of 21 CFR Part 211 and/or Part 4.
• Experience with process validation (IQ/OQ/PQ) and quality tools.

Responsibilities

• Review and approve change requests related to product and process.
• Develop and maintain quality documentation including SOPs.
• Ensure compliance with FDA and ISO requirements.
• Represent Quality in design reviews and project discussions.

Skills

Quality systems

Process validation

Regulatory compliance

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor's degree in Engineering or related field

Tools

SPC

DOE

FMEA

GR&R

CAPA

Job description

Stark Pharma is seeking a Senior Quality Engineer in Arden Hills, MN to enhance processes and ensure quality in drug-coated medical devices. The role requires expertise in quality systems, process validation, and compliance with FDA regulations. Ideal candidates will have 6-8+ years of experience in medical devices and solid understanding of industry standards. Responsibilities include reviewing change requests, maintaining quality documentation, and leading inspection activities.