Sr Director, Global Quality Management Systems (Hybrid - Acton, MA)
About The Position
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 foot print. Establishes, maintains and promotes a strategy for compliance with quality objectives. 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. 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). 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 level.
- 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 Cad or equivalent.
- NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.
Responsibilities
- Manage Regional and site-level Quality System compliance
- Ensure day to day manufacturing operations is completed in alignment with Operational targets and objectives
- Facilitate and support regional expansion plans for both new product launches and manufacturing foot print
- Establish, maintain and promote a strategy for compliance with quality objectives
- Ensure timely and accurate evaluations and investigations
- Implement prompt actions as necessary to ensure product safety and efficacy based upon investigation results
- Manage and ensure follow-up on activities related to Internal and External QMS Audits
- Establish, maintain and promote a culture of compliance and a keen focus on quality and customer requirements throughout the site organization
- Ensure an effective site Corrective and Preventive Action system
- Establish and maintain a robust employee training process
- Support and ensure establishment of a robust Environmental Monitoring program, if applicable for site
- Support and ensure sterilization controls and sterilization process validation program, if applicable for site
- Ensure 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
- Establish and maintain an effective and compliant site Document Control process
- Assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Director
