Supervisor, Incoming Quality

Job Summary

The Supervisor plays an integral part of Insulet’s Quality Department as the leader of Incoming Quality Assurance supervisor, as well as leading and managing inspections activities in accordance of FDA approved medical devices. The role requires strong organization skills and attention to detail while working in cross functional teams to accomplish departmental and company goals.

As an Incoming Quality Supervisor includes overseeing all aspects of quality control for materials entering a facility. They manage a team of inspectors to ensure that raw materials, components, and other goods meet specified standards before being used in production

Responsibilities:

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Team leadership and supervision

• Supervise, mentor, and provide day-to-day direction for the incoming quality control (IQC) inspection team.
• Develop training plans and conduct training sessions for technicians on inspection procedures, quality standards, and safety.
• Create and distribute work assignments and testing priorities to ensure an efficient workflow.
• Monitor team performance against key performance indicators (KPIs), such as non-conformance rates and inspection throughput.
• Arrange and manage resources to ensure efficiency of the inspection are continuous on time.
• Inspection and quality assurance
• Execute and implement IQC procedures, test plans, and sampling techniques.
• Inspect and approve incoming materials and components for compliance with specifications, using tools like calipers, micrometers, and CMMs (Coordinate Measuring Machines, Smartscope eg. OGP, etc).
• Review inspection documentation for accuracy and compliance with quality protocols.
• Perform lots acceptance in system upon pass inspection
• Ensure that all inspection equipment is properly maintained and calibrated.

Problem-solving and continuous improvement

• Manage the process for handling non-conforming materials, from quarantine to disposition.
• Lead or participate in root-cause investigations for quality issues found in incoming materials.
• Interface with supplier quality engineers to manage and resolve quality problems and implement corrective and preventive actions (CAPAs).
• Analyze inspection data to identify trends and recommend improvements to internal processes or supplier quality.

Documentation and compliance

• Maintain accurate and detailed records of all inspection activities and results.
• Prepare and present reports on quality metrics and inspection performance for management and other departments.
• Ensure the IQC department operates in compliance with internal policies, industry regulations, and quality management systems like ISO 13485.
• Participate in internal gemba walk and external audits to ensure compliance.
• Publish and reporting quality inspection data and performance.

Communication and collaboration

• Act as the primary point of contact for internal stakeholders relate to incoming activities, such as engineering, production, and purchasing, regarding incoming material quality.
• Communicate with production staff and leadership to resolve quality-related questions and issues.
• Collaborate with other quality teams to ensure quality standards are met throughout the entire production process.

Preferred Skills and Competencies:

• Education and/or experience in engineering, technical, management or scientific discipline.
• Prior experience working in a regulated industry such as Quality System Regulations 21CFR820 and/or ISO 13485.
• Ability to handle team interpersonal conflicts and find an acceptable resolution.
• Effective verbal communication and excellent technical writing skills.
• Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.
• Experience creating and analyzing trend and pareto charts.
• Experience or certification in process improvement and ISO process controls.
• Excels at generating and maintaining organized and accurate records.
• Experience with Microsoft software.

• Prior supervisory / team leadership experience.

Responsibilities:

Hires, manages, and mentors direct reports including daily interactions and performance reviews.

Provides leadership to team members, including but not limited to, training support on processes and

procedures.

Schedules work of direct reports to achieve business goals and objectives.

Establishes and tracks daily team metrics to ensure performance targets are achieved.

Performs complex tasks to ensure compliance with quality standards.

Works with Quality Engineers, and other team members, to ensure effective inspection and test procedures are implemented and maintained.

Works on the development of standards to meet quality specifications and recommends procedural

changes.

Collaborates with Quality Engineers with equipment troubleshooting and failure analysis.

Reviews applicable DHR documentation including inspection records, non-conformances, and deviations.

Manages, facilitates, and participates in continuous improvement projects.

Approves / signs-off work of Quality Technicians

Performs other duties as assigned.

Education and Experience:

Minimum Requirements:

Bachelors degree or equivalent experience

Combined 5 years of Quality Technician and/or supervisory experience

Preferred Skills and Competencies:

Education and/or experience in an engineering, technical or scientific discipline.

Prior experience working in a regulated industry such as Quality System Regulations 21CFR820 and/or ISO 13485.

Ability to handle team interpersonal conflicts and find an acceptable resolution.

Effective verbal communication and excellent technical writing skills.

Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.

Experience creating and analyzing trend and pareto charts.

Experience or certification in Lean Six Sigma, SPC, ASQ, and/or ISO process controls.

Excels at generating and maintaining organized and accurate records.

Experience with Microsoft software.

Prior supervisory / team leadership experience.

Physical Requirements:

Sitting 30%, Standing 70%

Occasional handling (push/pull) and/or lifting up to 50lbs

Ability to operate inspection hand tools and instrumentation

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!