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Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

A Principal Quality Engineer is a key leader responsible for managing and coordinating multiple complex projects, leveraging advanced quality engineering tools and methodologies. As a recognized technical authority, this individual drives the development and implementation of innovative strategies to enhance products, processes, materials, and risk management practices across the product lifecycle.

This role requires the application of quality engineering principles, problem-solving skills, and a strong understanding of regulatory compliance and business requirements to ensure robust product and process performance. The Principal Quality Engineer also mentors and oversees technicians, supports cross-functional business initiatives, and proactively mitigates risk through effective process design and capability improvement.

Responsibilities

Scope & Responsibilities:

QMS Assessment & Gap Analysis

+ Support review of the existing MedAlliance QMS to identify areas of procedural non-compliance to practice

+ Evaluate current processes to ensure QMS meets all applicable regulatory requirements (ISO, FDA, GMP, etc.).

+ Evaluate current instruction level documents versus practice

+ Remediate gaps where possible through change control update of documentation

Training & Compliance Enforcement

+ Support development and delivering of training programs to employees on QMS requirements.

+ Support the promotion of a culture of compliance and accountability.

+ Provide guidance on adherence to SOPs, CAPA processes, and best practices.

+ Support compliance audits and coaching sessions with all levels within the organization.

Audit & Corrective Action Implementation

+ Support compliance audits and coaching sessions with all levels within the organization.

+ Work independently to remediate documentation compliance level findings

+ Monitor the effectiveness of remediation efforts and make necessary adjustments.

+ Collaborate with regulatory bodies and certification agencies as needed.

Qualifications & Requirements:

+ Bachelor’s degree in Quality Management, Engineering, Life Sciences, or related field.

+ 8+ years of experience in Quality Assurance, Compliance, or QMS remediation.

+ Strong knowledge of ISO 13485, 21CRF820, GMP, GLP, and other quality standards.

+ Experience with internal auditing, CAPA management, and risk assessment.

+ Excellent problem-solving skills and ability to drive process improvements.

+ Strong communication and training abilities to promote a compliance culture.

+ PMA level combination device experience preferred.

+ Certification in Quality Management (e.g., CQE, CQA, Six Sigma) is preferred.

+ Certification as a PMP (project management professional) is preferred.

Strategic Impact

+ Operations team member enabling manufacturing operations and the manufacturing key dependent processes.

+ Quality support to develop next gen process and ramp up to meet market requirements

+ Quality lead on support and implementation of revised QS

+ MDR quality lead

Key Interactions

+ Reports to a senior leadership position.

+ Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.

Qualifications

Qualifications & Requirements:

+ Bachelor’s degree in Quality Management, Engineering, Life Sciences, or related field.

+ 8+ years of experience in Quality Assurance, Compliance, or QMS remediation.

+ Strong knowledge of ISO 13485, 21CRF820, GMP, GLP, and other quality standards.

+ Experience with internal auditing, CAPA management, and risk assessment.

+ Excellent problem-solving skills and ability to drive process improvements.

+ Strong communication and training abilities to promote a compliance culture.

+ PMA level combination device experience preferred.

+ Certification in Quality Management (e.g., CQE, CQA, Six Sigma) is preferred.

+ Certification as a PMP (project management professional) is preferred.

Pay / Compensation

+ The expected pre-tax pay rate for this position is $93,816 - $160,000 per year. Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.

+ US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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**Job Locations** _US-CA-Irvine_

**ID** _2025-9110_

**Category** _Quality/Regulatory_

**Position Type** _Regular Full-Time_

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]