Manager, Supplier Quality Systems - Acton, United States - Insulet Corporation

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

Position Overview:
Manages Insulet's Quality programs, activities, and Responsibilities: supporting current operations and new product introductions. Manages Quality technical and engineering personnel. Interfaces with other Insulet departments (senior management, operations, engineering, service, etc.) as well as with suppliers and other external parties on issues
related to quality.

Responsibilities:

• Manage quality assurance toward achievement of quality goals. Establish and maintain company compliance to FDA QSR, ISO 13485, CMCAS and related standards, regulations, and requirements.

• Develop and/or manage quality programs and training.

• Review data and information and make accept/reject decisions about Products, Processes, Validations, etc.

• Maintain and track quality for the purposes of analysis, control, cost and management reports.

• Investigate product defects, rejects and systems failures with emphasis on corrective action. Provide hands-on leadership to implement failure analysis and corrective actions.

• Maintain accurate, timely and efficient inspection and / or complaint processing labs.

• Manage effective Material Review Board meetings assure timely disposition and effective corrective action.

• Manage Calibration activities and assure appropriateness of tooling, fixturing and equipment selection.

• Suggest methods for improving product quality, design, or manufacturing processes.

• Serve as a team member to provide quality engineering expertise to product development, improvement, or other teams.

• Assist with failure and hazard analysis for commercial product, and components.

• Supervise quality assurance engineers, inspectors, or other personnel.

• Performs other duties as assigned.

Education and Experience:

• BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.

• 5-10 years' experience in the FDA regulated environment.
Minimum Requirements:

• Experience in Quality in an FDA regulated industry; experience with QSR and ISO 13485.

• Experience with FDA and ISO 13485 Certification inspections.

• Experience with ETO sterilization methods preferred.

• Demonstrated experience managing and supervising diverse teams, preferably as a Quality or Operations Manager.

• Direct experience with reject / defect monitoring and improvement activities.

• Statistical techniques, process improvement efforts, and DOE experience is a plus.

Preferred Skills and Competencies:

• Effective verbal and excellent technical writing skills.

• Ability to communicate at multiple levels of an organization.

• Ability to organize and judge priorities.

• Excels at generating and maintaining organized and accurate records.

• Knowledge of Engineering principles using statistics and SPC tools.

• PC skill, word processing, spreadsheet, database.

• Able to work effectively in a high-stress, high-energy environment.

• Able to make effective decisions quickly based on vague or imperfect information.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-hybrid

Additional Information:

The US base salary range for this full-time position is $99, $149, 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.

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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