The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.
Let’s talk about Responsibilities:
Strategic Leadership & Team Management
Lead and develop QC teams across all sites, review and support team members’ development, identify training and provide opportunities to broaden experience; provide leadership, mentoring and guidance.
Foster a culture of collaboration, safety, and continuous improvement within the QC function.
Process & Compliance Management
Manage and optimize QC processes for production and global QC support, ensuring adherence to GMP, ISO, and company quality standards.
Responsible for the coordination of in-process and finished goods inspections, resolving quality issues using sound problem-solving techniques.
Ensure maintenance, filing and archiving of all records associated with the inspection process and tasks are performed timely.
Provide leadership and support to calibration team to ensure compliance and maintenance of the Calibration Management System.
Operational Excellence
Act with independence when making decisions to ensure conformity of product and adherence to quality procedures.
Ensure nonconforming products are appropriately managed and NC’s in Production are investigated timely with appropriate evaluation and disposition.
Develop and deliver training in QC procedures and product specifications, ensuring staff awareness of new and revised documents.
Improve existing Quality Control processes and procedures related to in-process inspection and final inspection and provide monthly reports and tracking and trending data against KPIs incorporating SPC.
Subject matter expert for Quality Control operations in transformation initiatives, collaborating with global teams to ensure process alignment and consistency.
Stakeholder Engagement
Subject matter expert for Quality Control operations in transformation initiatives, collaborating with global teams to ensure process alignment and consistency.
Health, Safety & Environment
Subject matter expert for Quality Control operations in transformation initiatives, collaborating with global teams to ensure process alignment and consistency.
Let’s talk about Qualifications and Experience
Builds positive working relationships across the business to ensure that QA is recognized as integral to business success and growth.
Develops procedures, processes, metrics and systems to manage and monitor quality compliance.
Continuous Improvement to identifies and addresses barriers.
Analyses non-conformance data and determines root/cause/corrective actions.
Capability of controlling and completing multiple issues with a clear sense of priority.
Self-directing and self-motivated with sound leadership and negotiating skills.
Excellent written and oral communication skills and the ability to pay attention to detail.
Computer literate in Microsoft, Oracle and other relevant software.
Required
Degree in Engineering or Science discipline with ISO standards training.
At least 5 years’ working experience in Quality Management positions in an ISO certified industry (pharmaceutical, medical devices, or equivalent highly regulated industries).
Preferred
ISO13485 Internal Auditor or Lead Auditor training.
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!
Top Skills
What We Do
ResMed provides medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders.
