About Us
Position overview:
This position is integral in providing QC support such as: controlling the inspection of incoming materials to support Insulet’s development and manufacturing areas, running incoming, in-process and final acceptance tests, and coordinating the calibration of equipment. The position requires the individual to be flexible and deal with changing priorities on an ongoing basis to inspect and test to Insulet quality documentation. As well as supervise and prioritize the work of inprocess and incoming inspectors.
JOB / DUTIES / RESPONSIBILITIES (Listed in order of importance)
- Supervise quality control technicians.
- Prioritize quality inspectors’ tasks.
- Inspection of incoming or in-process parts or finished goods.
- Maintain quality records in compliance with FDA QSR and ISO 13485 standards.
- Assist with complaint and failure investigations.
- Assist with test protocol and report development for validations.
- All other duties as assigned
Requirements
Knowledge / Education
- Associated Degree in engineering, a technical or scientific discipline plus comparable experience as a Supervisor
- ASQ CMI desired
Skills / Competencies
- Effective verbal and written communication skills. Ability to communicate at multiple levels of an organization.
- Computer skills: Word processing, spreadsheet, database…;
- Ability to organize and judge priorities.
- Ability to work independently and request help/supervision when necessary
- Ability to generate and maintain accurate records.
- Knowledge of basic statistical and quality control principals.
Physical Requirements
- Ability to lift up to 20 pounds
Job Experience
- 5-10 years experience in the Medical Device Industry.
- Minimum of 4 years as a mechanical inspector/tester in a regulated environment preferably the Medical Device Industry with high volume production.
- Experience in Quality in an FDA regulated industry; experience with QSR and ISO 13485.
- Experience with FDA and ISO 13485 Certification inspections.
- Demonstrated experience managing and supervising diverse teams
- Experience with ETO sterilization methods preferred
Skills / 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 skills, word processing, spreadsheet, database.
- Able to work effectively in a high-stress, high-energy environment
- Able to make decisions quickly based on vague or imperfect information
If you have the necessary skill set and are interested in joining a growing company, please submit an updated resume to jcarreiro@insulet.com
