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Senior QA Engineer

ResMed -
Indianapolis, IN

Job Details

Full-time

Qualifications

Team supervision
Supervising experience
Production validation processes
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Managing product quality assurance teams
Legal compliance
ISO 13485
FDA regulations

Full Job Description

The Senior Quality Engineer (Supply Chain & Distribution) is a key leadership role for an ambitious, self-driven professional who thrives on innovation, problem-solving, and delivering impactful results. This role focuses on leading and empowering high performing teams, managing quality systems, ensuring compliance, leading complex projects, and fostering collaboration across teams. The ideal candidate is analytical, relationship-oriented, and eager to contribute to operational excellence and continuous improvement within the distribution channel.

Key Responsibilities

Serve as a trusted advisor to stakeholders by building strong relationships that drive collaboration and shared success.

Communicate quality performance through metrics, audit findings, and project updates to leadership and cross-functional teams.

Lead and inspire a high-performing team by fostering collaboration, accountability, and continuous development.

Drive engagement and results with clear expectations, constructive feedback, and recognition of achievements.

Promote a culture of trust and inclusion that empowers individuals, encourages innovation, and supports professional growth.

Facilitate process improvement and standardization initiatives across diverse teams with varying levels of experience in formal process development.

Support Distribution operations in meeting quality, delivery, and cost targets while driving continuous improvement.

Develop, implement, and maintain SOPs and quality systems in compliance with industry regulations (ISO 13485 and MDSAP).

Oversee end-to-end management of NCP and CAPA processes across sites, including local on-hold process-related actions.

Manage execution of non-conformance and on-hold material processes to ensure compliance and timely resolution.

Identify and mitigate systemic quality risks using data-driven trend analysis and root cause investigation.

Ensure compliance with the Quality Management System (QMS), maintaining calibration, validation, and quality tools/processes.

Conduct structured root cause analysis (e.g., A3, 8D, DMAIC) and implement corrective and preventive actions (CAPA).

Manage large-scale quality projects, aligning resources, timelines, and deliverables to achieve measurable results.

Qualifications & Experience

Bachelor’s degree in engineering , Quality Management, Compliance, or related field.

5 years of experience in quality assurance/control within a manufacturing or distribution environment.

At least 2 years of experience managing or leading quality professionals in a multi-site or matrixed environment.

Expertise in regulatory compliance, process validation, and quality system management (ISO 13485, MDSAP, and FDA)

Strong interpersonal, relationship-building, and communication skills.

Self-motivated, with a demonstrated ability to work independently and drive impactful results.

Preferred Skills:

Experience in change management and process improvement.

Knowledge of structured problem-solving techniques (e.g., A3, DMAIC, 8D).

Familiarity with quality systems within a global or regional distribution environment.

Excellent written and oral communication and negotiating skills.

Strong multitasking skills with the ability to prioritize to the business needs

Work Environment:

Role with require travel based on business needs.

Physical requirements include walking, standing, sitting, and occasional lifting (up to 50 pounds).

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.

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