Quality Engineer

Job Title : Quality Engineer

Department : Quality

Reports To : DOQ

Position Summary :

The Quality Engineer works closely with the engineering group to understand critical to quality design characteristics / specifications;

and performs reviews ensuring the products comply with mandatory regulatory requirements. The Quality Engineer will help create, monitor, and improve ISO 13485 and 21 CFR 820 quality system procedures to ensure compliance requirements are met efficiently and effectively and in support of Now Diagnostics Inc. objectives.

Duties & Responsibilities :

• Determining quality improvement factors.
• Making sure processes adhere to quality standards.
• Preparing reports by collecting, analyzing and summarizing data.
• Working in accordance with deadlines for delivery of products.
• Actively participates in root cause analysis on failures CAPAs.
• Collects, organizes, monitors, and distributes information related to supplier quality and process improvement functions.
• Ensure that procedures and work instructions are documented according to corporate and ISO standards
• Establish and implement process control plans to include capability studies, gage repeatability and reproducibility (Gage R&R) studies.
• Provide quality related documents to the manufacturing floor, including control plans, control cards, visual aids and work instructions.
• Monitor production floor processes for conformance to control plans and customer requirements which includes fit, function, reliability, durability and reappearance criteria.
• Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review.
• Track nonconforming material and lead Material Review Board (MRB) efforts.
• Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
• Lead complaint investigations on returned product.
• Ensure that all quality inspections are conducted in a timely manner.
• Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21 CFR 820.

Position Requirements :

• Advanced proficiency in Microsoft Office products.
• Excellent communication (written and verbal) skills.
• Excellent organization skills.
• Must be able to work independently and in a team environment.
• Process Validation for a minimum of 2 years.
• Must be a degreed engineer.

Education Requirements :

• BS in Engineering and a minimum of 3 years' experience in the regulated medical device industry as a Quality Assurance Engineer.
• Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices and other applicable standards preferred.

No relocation fees / moving costs included

No sponsorship included

Note :

This job specification should not be construed to imply that these requirements are the exclusive standards of the position.

Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor.