Job Title: Quality Engineer

Reports To: Quality Manager

Location: Hicksville, NY

Salary: 100k-120k

Position Summary:

The Quality Engineer is responsible for maintaining, monitoring, and continuously improving key quality system elements to ensure compliance with regulatory standards and support manufacturing excellence. This role plays a critical part in upholding quality standards across ISO 13485:2016, ISO 9001:2015, AS 9100 Rev D, and FDA CFR Part 820.

Key Responsibilities:

Quality Systems Management

• Manage and execute the Internal Audit Program.

• Oversee the Non-Conformance (NC) and Corrective and Preventive Action (CAPA) systems.

• Maintain and improve the Quality Document Control System.

• Prepare and facilitate Management Reviews and Quality performance reports.

• Support the Document Control Request process.

Compliance & Regulatory Support

• Ensure compliance with ISO 13485, ISO 9001, AS 9100, and FDA CFR Part 820.

• Lead and participate in external audits.

• Collaborate with QE/QC and Validation teams to ensure integrated quality system implementation.

Data Analysis & Reporting

• Monitor and analyze quality metrics such as non-conformances, scrap, yield, and repeat NRFT (Not Right First Time) issues.

• Develop and present management-level reporting on quality performance.

Project & Continuous Improvement

• Lead and complete assigned Quality System Improvement Projects.

• Support cross-functional quality improvement initiatives.

General Responsibilities

• Promote a culture of quality and compliance across departments.

• Maintain work areas in accordance with GMP standards.

• -Report maintenance and Health & Safety issues promptly.

• Adhere to company Health & Safety policies, including PPE requirements.

Required Qualifications:

• Honours Degree in Quality, Mechanical, Manufacturing, or Production Engineering (or related field).

• Minimum 5 years’ experience in quality assurance within a production environment.

• Proven experience with GMP and ISO 13485.

• Familiarity with FDA CFR Part 820 and ISO 9001 is desirable.

• Proficient in MS Office and Quality Enterprise Systems.

• Skilled in formal problem-solving tools (e.g., 5 Whys, Fishbone, A3).

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance