Director, Quality Operations

Job Summary

The Director, Quality Operations will manage site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable country-specific regulatory requirements. This position will also perform role of site Quality System Deputy Management Representative with responsibility for ensuring processes needed for the Quality Management System (QMS) are documented, reporting to top management on the effectiveness of the QMS and any need for improvement, and ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization.

Responsibilities

• Leads a team of Quality Engineers (QE), Quality Control (QC), and Quality Assurance (QA) associates, ensuring strong performance, professional development, and effective collaboration with key stakeholders. Responsible for all aspects of Factory Quality, from Incoming Inspection through Final Product Release.
• Establishes, maintains, and promotes strategies to achieve quality objectives and ensure compliance with applicable quality and regulatory requirements.
• Ensures timely and accurate evaluations and investigations and implements appropriate actions to maintain product safety and effectiveness based on investigation outcomes.
• Manages and ensures timely follow-up of activities related to internal and external Quality Management System (QMS) audits.
• Establishes, maintains, and promotes a culture of quality, compliance, and customer focus throughout the organization.
• Ensures the effectiveness of the site's Corrective and Preventive Action (CAPA) system.
• Ensures the effectiveness of the site's Quality Planning process.
• Establishes and maintains a robust employee training program.
• Supports the establishment and maintenance of a robust Environmental Monitoring Program.
• Ensures that products are not released for distribution until all Device Master Record (DMR) requirements have been met.
• Responsible for establishing and maintaining effective and efficient statistically based Quality Control processes, including incoming, in-process, and finished product inspection and release.
• Ensures company operations comply with all applicable laws, regulations, standards, good business practices, and documented company procedures, including all occupational health, safety, and environmental regulations applicable to the site.
• Partners with key global stakeholders to drive harmonization, standardization, and continuous improvement initiatives.
• Engages, promotes, and participates in Environmental, Health, and Safety (EHS) initiatives, with a focus on continuous improvement.

Key Decision Rights

• Serves as a member of the IMY Plant Leadership Team (PLT) and partners with key site and global stakeholders.
• Serves on the IMY Material Review Board (MRB) Committee.
• Acts as the IMY Management Representative and serves as a key stakeholder during internal, external, and regulatory audits.
• Serves on the IMY CAPA Change Review Board (CRB) Committee.
• Owns and manages the budget for all IMY Quality Assurance Operations.

Required Leadership / Interpersonal Skills & Behaviours

• Collaborates effectively and drives continuous improvement across functions and global teams.
• Identifies and leads continuous improvement opportunities.
• Aligns team objectives with broader organizational goals and objectives and tracks progress against established targets.
• Leads, develops, and mentors a team of quality professionals in a fast-paced environment.

Required Skills and Competencies

• Demonstrated ability to make risk-based decisions in collaboration with others and in accordance with established Quality Management System (QMS) processes.
• Excellent communication skills and the ability to work collaboratively with cross-functional teams.
• Global mindset with the ability to work effectively in a matrixed organization.
• Broad quality experience, including Incoming Quality, Quality Assurance, Quality Control, Quality Engineering, and Quality Systems.
• Strong analytical skills with the ability to interpret complex data and drive effective decision-making.

Education and Experience

• Bachelor’s degree in Science, Engineering, or a related discipline is required.
• A minimum of 12 years of experience in Medical Device Quality Operations, including at least 10 years in a Quality Manager or equivalent leadership role. Experience in high-volume electromechanical device manufacturing is preferred.
• Broad knowledge of manufacturing, product development, engineering processes, equipment, methodologies, and techniques.
• Significant knowledge and experience in designing, implementing, and maintaining Quality Management Systems and manufacturing processes that comply with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
• Intermediate to advanced proficiency in Microsoft Word, Excel, Data Analytics tools, Power BI, or equivalent software.

• Additional Information
• This position is based on-site at the Insulet Malaysia (IMY) manufacturing facility.
• Travel is estimated at approximately 10% and may vary based on business needs.

• Note: This position requires on-site work and is not eligible for remote or hybrid work arrangements.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.