Principal Engineer, Product Quality Compliance

New World Medical•Rancho Cucamonga, CA

About The Position

New World Medical is a mission-driven company focused on preserving and enhancing vision through innovative 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 standards or regulatory gap assessments. The position manages and supports documentation for product and quality-system compliance, maintains compliance target lists, leads gap and remediation assessments, and coordinates with Engineering and Design Assurance to determine applicable standards and required validation activities. It also manages product-documentation reviews and revisions, leads process and procedure improvements, supports third-party and regulatory audits, and helps ensure ongoing QMS compliance. The role represents Quality Assurance in cross-functional meetings, provides compliance expertise during audits and inquiries, stays current on organizational and industry information, and mentors others on compliance practices. The position requires strong organizational, communication, problem-solving, regulatory interpretation, training, project-management, and leadership capabilities. A bachelor’s degree in a relevant field or equivalent combination of education and work experience is required, along with at least eight years of experience in Quality or a related field.

Requirements

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.
At least 8 years of experience in Quality or a related field.
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 multidisciplinary project teams and resolving quality-related issues effectively and promptly.
Proficiency with Microsoft Word, Excel, Outlook, PowerPoint, and Visio, including statistical and data analysis and report writing.
Strong verbal and written communication skills, with the ability to communicate effectively at multiple organizational levels.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Ability to remain stationary at least 50% of the time and work at a computer; occasionally move about inside the office and travel to and from office buildings, including bending and walking.
Ability to operate a computer and office productivity equipment such as a printer, keyboard, and calculator.
Ability to occasionally lift up to 15 pounds, with reasonable accommodation if needed.
Ability to view and type on computer screens for long periods.

Nice To Haves

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

Responsibilities

Manage and support the 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 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 identify applicable standards for product lines and document validation or other activities required for compliance.
Manage reviews and revisions 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 the QMS’s continued compliance with regulatory requirements and compliance targets.
Maintain required training and seek 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.