Job Description
Job DescriptionJob 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
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Manage and execute the Internal Audit Program.
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Oversee the Non-Conformance (NC) and Corrective and Preventive Action (CAPA) systems.
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Maintain and improve the Quality Document Control System.
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Prepare and facilitate Management Reviews and Quality performance reports.
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Support the Document Control Request process.
Compliance & Regulatory Support
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Ensure compliance with ISO 13485, ISO 9001, AS 9100, and FDA CFR Part 820.
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Lead and participate in external audits.
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Collaborate with QE/QC and Validation teams to ensure integrated quality system implementation.
Data Analysis & Reporting
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Monitor and analyze quality metrics such as non-conformances, scrap, yield, and repeat NRFT (Not Right First Time) issues.
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Develop and present management-level reporting on quality performance.
Project & Continuous Improvement
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Lead and complete assigned Quality System Improvement Projects.
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Support cross-functional quality improvement initiatives.
General Responsibilities
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Promote a culture of quality and compliance across departments.
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Maintain work areas in accordance with GMP standards.
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-Report maintenance and Health & Safety issues promptly.
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Adhere to company Health & Safety policies, including PPE requirements.
Required Qualifications:
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Honours Degree in Quality, Mechanical, Manufacturing, or Production Engineering (or related field).
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Minimum 5 years’ experience in quality assurance within a production environment.
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Proven experience with GMP and ISO 13485.
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Familiarity with FDA CFR Part 820 and ISO 9001 is desirable.
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Proficient in MS Office and Quality Enterprise Systems.
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Skilled in formal problem-solving tools (e.g., 5 Whys, Fishbone, A3).
Pay Details: $100,000.00 to $120,000.00 per year
Search managed by: Cara Kelly
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