Manager, Quality Operations

Manager, Quality Operations

Insulet

Waalwijk, Netherlands

Position Overview:

The Quality Operations Manager will manage site-level Quality System compliance, ensuring full compliance of the site quality System with US FDA, ISO 13485, MDSAP/MDR and other applicable country specific regulatory requirements. Specific focus will be on QC testing, documentation review, and product release. This position will also perform role of Site Quality System Deputy Management Representative and Safety Officer. Includes responsibility to ensure processes needed for the Quality management System (QMS) and safety are documented reporting to top management on the effectiveness of the QMS and safety and any improvement and ensuring promotion of awareness of applicable regulatory requirements and QMS requirement throughout the organization.

Responsibilities:

• Establishes, maintains, and promotes a strategy for compliance with quality objectives.
• Ensure product is tested in accordance with company policies and procedures.
• Ensure product release is conducted in accordance with company policies and procedures.
• Ensures product is not released for distribution until all Device Master Record requirements have been met.
• 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/regulatory requirements and a keen focus on quality and customer requirements throughout the site organization.
• Establishes and maintains a robust employee training process.
• Manage direct reports to ensure timely completion of activities to support release of products.
• Establish and maintain an effective and compliant site Document Control process.
• Approve/Sign-off work of direct reports and other team members.
• Identify process improvement opportunities to enhance surveillance and to increase efficiency.
• Participate in and lead cross-function and cross-location activities to improve efficiency and compliance.
• Support, as site manager, Global Product Monitoring lab to complete investigations on a timely and compliant level.
• This position is required to support 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).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Supports and ensures establishment of a robust Environmental Monitoring program, if applicable for site.
• Infrastructure: buildings, workspace, and associated utilities: The site manager supports maintenance of the building, as well as for its workspace and associated utilities.
• Maintain process equipment, both hardware and software.
• Safeguard control of monitoring and measurement equipment controlled and protected from damage.
• Support a good relationship with (potential) suppliers/landlord.

Requirements:

• Bachelor's degree (preferably science or engineering discipline) required.
• At least 7 or more years of experience in Medical Device Quality Operations.
• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development, and engineering.
• Significant knowledge and experience with designing and implementing 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