Quality Engineer II
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At a glance
Requirements
Credentials this posting asks for.
Job overview
ICONMA, LLC is hiring a Quality Engineer II. The Quality Engineer II will ensure compliance and quality for product-related risk management documentation within a medical device and healthcare company. This role involves supporting product risk management activities across the product lifecycle, performing hazard and risk assessments, and contributing to continuous improvement of risk management processes. The engineer will work cross-functionally with various teams to maintain compliant risk management documentation in alignment with FDA regulations and ISO standards.
Key focus areas include Establish and ensure compliance and quality for product related risk management documentation, Ensure risk management assessments and evaluations conform to established standards and agency regulations, and Support product risk management activities across the product lifecycle.
Successful candidates bring Bachelor's Degree In Engineering, 3+ Years Quality Engineering Experience, and Certified Quality Engineer. Important skills include Risk Management Documentation, Hazard And Risk Assessments, Continuous Improvement Of Risk Management Processes, Audit-Ready Documentation, Quality Improvements Related To Risk Management Processes, and FDA Regulations. Preferred (not required): Complaint Handling, Medical Device Regulatory Environments, and Complaint Management.
Skills & qualifications
Skills
Qualifications
Benefits
Full job description
Our client, a Medical Device and Healthcare company, is looking for a Quality Engineer II for their Scarborough, MElocation. Responsibilities:
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Works closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.
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This role will support product risk management activities across the product lifecycle, including evaluating risks associated with complaints, manufacturing non-conformances, and new product development.
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The Quality Engineer II will work cross-functionally with Engineering, Manufacturing, Regulatory, and Quality teams to establish and maintain compliant risk management documentation in alignment with FDA regulations and ISO standards.
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Responsibilities include performing hazard and risk assessments, contributing to continuous improvement of risk management processes, and ensuring product risk documentation is accurate, complete, and audit-ready.
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A strong understanding of complaint handling, health hazard assessments, and medical device regulatory environments is preferred.
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Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
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Proactive in finding quality improvements related to Risk Management processes.
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Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation.
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Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
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Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
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Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements:
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Bachelor’s degree in Engineering or related technical field
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Minimum 3 years of experience in quality engineering within a regulated environment (medical device, pharmaceutical, or similar)
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Hands-on experience with product risk management, including hazard analysis and risk assessments (ISO 14971)
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Experience supporting complaint investigations, non-conformance evaluations, or health hazard assessments
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Working knowledge of FDA regulations, ISO standards, and quality systems
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Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams
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Strong analytical, problem-solving, and documentation skills
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Certified Quality Engineer (CQE) or equivalent
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Experience with GMP environments and quality system audits
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Exposure to new product development and design assurance activities
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An equivalent combination of education and work experience
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Minimum 2 years, in a medical device, regulatory environment or pharmaceutical manufacturing.
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Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) products.
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Must have fundamental knowledge of concepts, practices, and procedures of a particular field of specialization.
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Credentials of a Certified Quality Engineer are a plus.
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Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
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Must possess good communication and analytical skills.
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Ability to work under deadlines.
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Demonstrated use of Quality tools/methodologies.
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Solid communication and interpersonal skills.
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Ability to resolve quality-related issues in a timely and effective manner.
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Demonstrates technical leadership within the department and outside the department.
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Experience working in a broader enterprise/cross-division business unit model preferred.
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Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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Ability to leverage and/or engage others to accomplish projects.
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Strong organizational and follow-up skills, as well as attention to detail.
Why Should You Apply?
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Health Benefits
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Referral Program
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Excellent growth and advancement opportunities
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