Senior Manager, Quality Operations (On-site - Acton, MA.) at Insulet in Acton, Massachusetts

Job Description:

The Senior Manager of 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:

• Ensure all product testing and release (including management of non-conforming material) from Incoming, In-process, Lot Qual through pre-sterile release is handled in a compliant and efficient manner.


• 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.


• Performs other duties as required.

Management Responsibilities:

• Responsible for the day-to-day management of a group of employees.


• Performance management: Monitor employee performance, provide feedback, and address performance issues


• Goal setting: Set goals for the team and ensure employees understand how their work contributes to company objectives


• Team development: Recruit, train, and develop new employees who fit the company's culture


• Employee engagement: Create a supportive and inclusive work environment

Minimum Requirements:

• Bachelor's degree required.


• At least 10 or more years of experience in a regulated environment with 5 or more years at the Quality Manager level.

Preferred Skills and Competencies:

• Degree in a science or engineering discipline preferred.


• Experience in the medical device or pharmaceutical industry strongly preferred.


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


• Excellent interpersonal, verbal and written communication skills.


• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.


• Ability to communicate and work effectively at multiple levels within the organization.


• Advanced PC skill, word processing, spreadsheet, and database.

Travel Requirements:

• As required as dictated by the needs of the business (up to 25%)

Physical Requirements:

• The quality manager's physical requirements involve the ability to walk, stand, and occasionally bend or reach within an environmentally controlled production facility which includes frequently entering the cleanroom. Often spend long periods sitting at a computer while also being able to move around to inspect products or processes, which may include occasional lifting.

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

Additional Information:
The US base salary range for this full-time position is $136,650.00 - $204,975.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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