Quality Engineer (Medical Device Industry Experience required), Temporary, Remote

Northwell • Village of New Hyde Park, NY

5h • Remote

About The Position

FlexStaff is seeking a Quality Engineer with experience in Medical Device manufacturing to work with one of our clients, a leading global distributor of healthcare products and services for their manufacturing division in Ontario, California.
This is a contract job until June 30, 2026.
Schedule: Monday to Friday, 11am- 8:30pm EST.
What You'll Do:
Develop and implement systems to ensure products and/or services are designed and produced to meet or exceed customer expectations and regulatory requirements, including the US Food and Drug Administration, Health Canada, European MDD/MDR.

Requirements

• Three (3) or more years of experience in product engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry.
• A Bachelor's Degree in engineering
• Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards.

Responsibilities

• Continuous Improvement: Identify and recommend enhancements in product design and manufacturing processes. Provide quality engineering support for risk management, design changes, and CAPA investigations.
• Quality System Expertise: Author, review, and approve Quality System documentation, including NCMR and Engineering Change Control.
• Supplier Quality Improvement: Drive supplier quality through engineering analysis and root cause investigations. Collaborate with suppliers to reduce defects and improve yield.
• Trend Analysis: Conduct periodic product and process trend analyses to ensure quality, patient safety, and regulatory compliance. Implement corrective actions and problem-solving methodologies to reduce defects.
• Product Development Guidance: Offer quality engineering insights for product and process improvements, validating design inputs related to usability, reliability, safety, and manufacturability.
• Quality Control Planning: Assure product quality in line with best practices, including material control and process validation, based on risk management outcomes.
• Validation and Testing: Author validation and inspection assessments to ensure product release readiness. Select tests and sampling sizes based on criticality.
• Regulatory Compliance: Stay updated on relevant quality standards (e.g., Medical Device Directive, US FDA) and adapt quality processes to meet changing requirements.
• Computer System Validation: Perform computer system validation and ensure adherence to regulatory standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level