Senior Director, Quality Operations

Insulet; Gelang Patah; On-site; MYR 80,000 - 150,000; Full time

Job summary

Join a forward-thinking company as a Senior Director of Quality Operations, where you will lead compliance and quality initiatives across APAC manufacturing sites. This role offers the opportunity to shape best practices, drive operational efficiencies, and ensure product safety in a dynamic environment. Your expertise in Medical Device Quality Operations will be crucial in supporting the organization’s growth and regulatory compliance. Collaborate with a talented team to promote a culture of quality and compliance, making a significant impact on the lives of patients through innovative technology. If you are passionate about quality and leadership, this is the perfect opportunity for you!

Qualifications

• 15+ years in Medical Device Quality Operations, 10+ years at Manager/Director level.
• Broad knowledge of manufacturing, development, and engineering processes.

Responsibilities

• Manage Quality System compliance with FDA, ISO 13485, and other regulations.
• Lead operational efficiencies and compliance across manufacturing sites.

Skills

Medical Device Quality Operations

Quality Management Systems (QMS)

ISO 13485

FDA Regulations

Statistical Process Control

Team Leadership

Regulatory Compliance

Education

Bachelor's degree in Science or Engineering

Tools

MS Word

MS Excel

MS Access

AutoCAD

Job description

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.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Job Title: Senior Director, Quality Operations

Department: Quality Operations

Manager/Supervisor: VP, Global Quality Operations

FLSA Status: Exempt

Responsibilities:

The Sr. Director of Quality Operations will manage Regional and site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable regional and/or country-specific regulatory requirements. The position will ensure day-to-day manufacturing operations is completed in alignment with Operational targets and objectives, as well as facilitate and support regional expansion plans for both new product launches and manufacturing footprint . The position will support the Global Supplier Quality processes by providing in-region supplier oversight, as well as leadership for in-region Supplier Quality team members.

• Create and implement best practice quality vision, strategy, policies, processes, and procedures to aid and improve business performance. Lead and drive operational efficiencies and compliance across APAC Insulet manufacturing sites .

• As a senior leader on the Global Quality Operations team, helping to identify and drive cross-factory improvements in efficiency and compliance.

• Scope of role includes both Insulet factories as well as oversight of contract manufacturing in region.

• Ensures timely and accurate evaluations and investigations. Implements prompt actions as necessary to ensure product safety and efficacy based upon investigation results.

• Manages and ensures follow-up on activities related to Internal and External QMS Audits.

• Establishes, maintains and promotes a culture of compliance and a keen focus on quality and customer requirements throughout the site organization.

• Ensures an effective site Corrective and Preventive Action system.

• Establishes and maintains a robust employee training process.

• Supports and ensures establishment of a robust Environmental Monitoring program, if applicable for site.

• Supports and ensures sterilization controls and sterilization process validation program, if applicable for site.

• Ensures product is not released for distribution until all Device Master Record requirements have been met.

• Responsible for establishing and maintaining effective and efficient statistically-based Quality Control processes, i,e , incoming, in-process, and finished product inspection and release.

• Support interactions with regulatory bodies and ensure compliance with all applicable quality and safety standards (internal and external) . Guide the activities required of the quality organization to ensure compliance with all appropriate regulations and standards, including FDA Part 820, ISO 13485, MDSAP.

• Proactively work to ensure the organization has the right structure and competencies to meet the current and future needs of the business. Create and build confidence by establishing the quality function as an informed, capable, knowledgeable, and accessible resource to staff, management, and stakeholders.

• Establish and maintain an effective and compliant site Document Control process.

• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).

• Provides in-region Quality Executive support for the Global Supplier Quality process. This may include engagement with in-region suppliers as well as indirect leadership of in-region Supplier Quality team members.

• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Requirements

• Bachelor's degree (preferably science or engineering discipline) required .

• At least 15 or more years of experience in Medical Device Quality Operations with 10 or more years at the Quality Manager / Director level.

• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development and engineering.

• Significant knowledge and experience with implementing and executing QMS processes that meet the requirements of ISO 13485, 21 CFR 820, and MDR.

Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent.

NOTE: The ideal candidate is based in the APAC region (ideally in Malaysia) , and able to travel within region (Malaysia and China) as well as internationally (US and Europe).