Senior QA Engineer (Manufacturing Quality)

Description

Summary

As part of the Manufacturing Quality function, the Senior QA Engineer (Manufacturing Quality) plays a pivotal role in designing, implementing, and monitoring quality control programs. This position is responsible for recommending improvements to methods, procedures, and standards based on data analysis to enhance quality and ensure compliance with regulatory standards. You will ensure that products meet specifications and quality standards, identifying and resolving defects as necessary.

Key Responsibilities

Quality, Delivery, and Cost : Collaborate with Factory Focus teams to drive the achievement of KPIs in these areas.

New Product Introduction : Lead and support the introduction of new products into manufacturing, working closely with cross-functional teams (XFT) and QA counterparts.

System and Process Improvement : Proactively enhance quality systems to support manufacturing and ensure consistency and standardization across various manufacturing units and sites within ResMed.

Risk Management : Identify and mitigate the risks of non-compliance and related business risks.

Leadership and Mentoring : Provide quality and technical leadership through mentoring and coaching to junior team members.

Compliance Assurance : Ensure full compliance with ResMed QMS and applicable regulatory standards.

Cross-functional Collaboration : Engage with multiple QA functions, including quality systems & audits, design, supplier quality, manufacturing, and customer quality.

Operational Support : Act as the quality representative for projects and activities requiring broad quality expertise, including site expansions and process integration.

Documentation and Audits : Develop Quality Agreements, Plans, and perform or support internal / external / supplier audits.

Stakeholder Engagement : Partner with internal and external stakeholders to define quality requirements and make informed, risk-based decisions to ensure successful outcomes.

Qualifications and Experience

Required :

Educational Background : Bachelor’s degree in Engineering or Science.

Experience : Minimum of 5 years in a regulated, volume manufacturing industry, with experience in Quality Systems, Manufacturing Quality, Risk Management, and Process Validation.

Self-Starter : Ability to work independently with minimal supervision and a strong sense of urgency.

Strong Organizational Skills : Excellent planning and organizational abilities with the ability to take initiative and ownership.

Interpersonal Skills : Strong communication and negotiation skills, capable of engaging effectively with senior management and managing stakeholders.

Global Team Collaboration : Proven ability to work with global teams, maintaining good relationships while influencing change.

Preferred :

Industry Experience : Experience in Quality and / or Regulatory positions within the medical device industry.

Specialized Knowledge : Expertise in Quality Systems, Manufacturing Quality, Process Validation, and Risk Management.

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!