Principal Engineer, Product Quality Compliance

New World Medical, Inc.•Rancho Cucamonga, CA

2h•$130,000 - $145,000

About The Position

New World Medical is a mission-driven company focused on preserving and enhancing vision through ophthalmic surgical devices. The Principal Engineer, Product Quality Compliance ensures company products comply with testing and characteristic standards. The role reviews requirements and identifies and leads improvement or remediation projects to maintain compliance with applicable requirements, including CAPAs, certification audit responses, and standard or regulatory gap assessments. The position manages compliance documentation and target lists for medical devices and the quality system, leads gap and remediation assessments, and works with Engineering and Design Assurance to determine applicable standards and required validation activities. It manages reviews and revisions of product documentation, supports process and procedure improvements, third-party and regulatory audits, and ongoing QMS compliance. The role also provides compliance expertise during audits and inquiries, represents QMS QA in cross-functional meetings, and shares current compliance practices through training and mentorship.

Requirements

Ability to work independently and as part of a team, and to lead a team.
Excellent organizational and communication skills and strong attention to detail.
Problem-solving and creativity skills.
Ability to interpret, understand, and communicate applicable regulatory requirements.
Ability to train others on quality system and regulatory requirements, concepts, and quality procedures.
Demonstrated project management and leadership skills, including leading multi-departmental project teams and resolving quality-related issues in a timely and effective manner.
Proficiency in Microsoft Word, Excel, Outlook, PowerPoint, and Visio, including statistical and data analysis and report writing skills.
Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Bachelor’s degree, preferably in Engineering, a technical field, life science, or a closely related discipline, or an equivalent combination of education and work experience.
Minimum 8 years of experience in Quality or a related field.

Nice To Haves

Experience in standard review and product testing in accordance with standard requirements is highly preferred.

Responsibilities

Manage and support creation of documentation to maintain product and quality system compliance with recognized standards, in conjunction with product engineers.
Manage and update compliance target lists for New World Medical devices and the quality system.
Lead gap assessments when product compliance targets change or are revised; perform remediation assessments and outline remediation requirements.
Work with Engineering and Design Assurance to determine applicable standards for product lines and identify and document validation or other activities required to ensure compliance.
Manage the review and revision of product documentation to ensure continued compliance with regulatory targets.
Lead and support process or procedure improvement projects to ensure continued QMS compliance.
Support third-party and regulatory compliance audits, including MDSAP, ISO 13485, and MDR audits.
Maintain continued QMS compliance with regulatory requirements and compliance targets.
Maintain position training requirements and pursue opportunities for growth and continuous development.
Represent QMS QA in cross-functional meetings.
Adhere to and identify opportunities to improve the QMS and its processes.
Stay current with organizational and industry information and mentor or lead others on new or revised compliance practices.
Provide compliance subject matter expertise during audits, inspections, and inquiries.