Director, Quality Operations (On-site)

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.

The Director, Quality Operations will manage product and process Quality, as well as Quality System compliance of the site Quality System with US FDA, ISO 13485, and other applicable country-specific regulatory requirements. This role will also play a crucial role in providing Quality oversight for the entire Acton, MA factory manufacturing process to ensure efficiency, effectiveness, and delivered product performance. The position reports to the Vice President, Global Quality Operations.

Responsibilities

· Leads a team of factory QE, QC, and QA Quality associates, ensuring performance, growth, and collaboration with key stakeholders. Responsible for all aspects of Factory Quality, from Incoming Inspection through Final Release.

· 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.

· Ensures an effective site Quality Planning system.

· Establishes and maintains a robust employee training process.

· Supports and ensures establishment of a robust Environmental Monitoring 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.

· 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).

· Partners with other key stakeholders globally to drive harmonization and improvement.

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

Key Decision Rights

· Part of the Acton factory leadership team and partners with key site and global stakeholders.

· Serves on Acton factory MRB.

· Serves as Acton Deputy Management Representative and will be a key stakeholder during audits.

· Serves as Acton CAPA CRB chair.

· Budget owner for multiple cost centers.

Required Leadership/Interpersonal Skills & Behaviors

· Collaborate and drive improvement cross-functionally and globally.

· Identify and drive continuous improvement opportunities.

· Align with the larger strategic goals and objectives, and track progress to targets.

· Lead and develop a team of quality professionals in fast paced environment .

Required Skills and Competencies

· Ability to make risk based decisions in concert with others, and according to established QMS processes.

· Excellent communication skills and the ability to work collaboratively with cross-functional teams.

· Global mindset and ability to work effectively in a matrixed organization.

· Broad spectrum Quality experience, including Incoming Quality, Quality Assurance, Quality Control, Quality Engineering, Quality Systems.

· Strong analytical skills and the ability to interpret complex data.

Education and Experience

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

· 10+ years of experience in Medical Device Quality Operations with several or more years at the Quality Manager level. Ideal experience would be in high-volume electromechanical devices.

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

· Significant knowledge and experience with designing and implementing QMS and production 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.

Additional Information

· The position is in person at our Acton, MA USA flagship manufacturing facility (hybrid working arrangement possible).

· Travel is estimated at 10% but will flex depending on business need.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite  

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