Associate Manager, Qa
vor 2 Monaten
Lead a team of Quality Engineers, guiding the QA PFT team to maintain and enhance existing policies, processes, and metrics in line with business strategy and regulatory requirements.
Ensure effective resource allocation and prioritization to meet ResMed's quality, delivery, and cost targets.
Foster a highly engaged, self-empowered, and capable team through mentorship and leadership.
Provide technical guidance and support to the team, ensuring alignment with best practices and industry standards.
Oversee the implementation of risk management processes across ResMed Operations.
Support and participate in internal audits, and assist with external quality system audits as needed.
Manage product and performance non-conformances, ensuring thorough root cause analysis, corrective/preventive actions, and effectiveness checks in collaboration with relevant functions.
Continuously improve the ResMed quality system and data reporting mechanisms to support production and GMP compliance, working closely with colleagues across sites.
Foster a strong business partnership with key stakeholders to implement effective business strategies that enhance operational performance and support organizational objectives.
Drive continuous improvement initiatives that align with the strategic imperatives of the business.
Contribute cross-functionally, providing input and support for new product development and ongoing process improvements.
Monitor site compliance with quality standards, regulatory requirements, and other business systems.
Ensure the implementation and monitoring of management systems within your area of responsibility, including health & safety, quality, and environmental management.
Let's Talk about Qualifications & Experience:
Required:
Bachelor's degree with at least 5 years of experience in Quality, Regulatory, or Manufacturing Engineering, working within a Quality Management System (QMS) in an ISO-certified, highly regulated industry (e.g., pharmaceutical, medical devices).
Strong knowledge of GMP and national/international quality and regulatory standards, including ISO 13485, FDA Quality System Regulations, Health Canada Medical Device Regulations, Australian Therapeutic Goods (Medical Devices) Law, Japanese Pharmaceutical Affairs Law, and European Medical Devices Directive.
1-3 years of people management experience in a similarly regulated medical industry.
Proven ability to identify, evaluate, and resolve key quality issues.
Exceptional leadership, collaboration, and influencing skills, with experience managing competing priorities in a fast-paced environment.
Excellent written and verbal communication skills.
Preferred:
Experience with high-volume manufacturing processes.
Familiarity with total quality management (TQM) principles and best practices.
Experience in process validation and risk management methodologies.
In-depth knowledge and practical experience with business management systems, GMP, Lean, 5S, and Six Sigma methodologies.
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
About Us At ResMed (NYSE: RMD, ASX: RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives.
Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD and other chronic diseases.
Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.
By enabling better care, we improve quality of life, reduce the impact of chronic disease and lower costs for consumers and healthcare systems in more than 140 countries.
To learn more, visit ResMed.com and follow @ResMed.
ResMed Corporation is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
(US/Canada only) ResMed is an equal opportunity/affirmative action employer.
ResMed is an E-Verify Employer.
ResMed is a smoke-free workplace.
We are a 2024 Circle Back Initiative Employer – we commit to respond to every applicant
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