Position overview: This position is an integral part of
Insulet’s Quality Department and provides support to the
activities for new product development. Serve as a team
member and makes suggestion during inspection process
evaluation and participates during engineering
development validations to ensure compliance to the
standards and protocols. It requires organization and
attention to detail while working with other Quality
functions and engineers to ensure compliance and the
accomplishment of departmental and company goals.
JOB / DUTIES / RESPONSIBILITIES
support of Quality System, e.g., training, NCR,
- Generate, review and maintain Quality records in
CAPA’s and deviations.
development and special projects.
- Assist the QA Engineering staff on new product
- Develop an understanding of the new product.
- Help establish initial FAI methodology on new
completeness and dimensional measurability.
- Help review component and sub-assembly drawings for
measurement fixtures and GR&R’s.
- Assist with evaluation of new component inspection
product development qualifications.
- Follow-up with suppliers as required during new
Engineering management; assist with closure of the
- Perform simple tolerance stack-up analyses.
- Communicate any quality-related problems to the QA
problem and remedial and corrective actions.
- Assist with and write Test Protocols and Reports.
- Maintain the CAPA Matrix summary for Complaint Lab
investigations and Root Cause Analysis and drive
- Train new employees to summarize complaint
further action, when requested.
- Team reference for certain Pilgrim interface issues.
- Able to accomplish multiple assignments
- Assist in gathering information during FDA and ISO
- Other duties as assigned.
Knowledge / Education
- AS degree in a technical field, or equivalent work
Device Industry preferred).
- Minimum of 3 years in a regulated industry (Medical
related function working with QSR and/or ISO 13485.
- Minimum of 3 years in a Quality of manufacturing
- Basic knowledge of some fundamental using statistics
Skills / Competencies
- Effective verbal and excellent technical writing
multiple levels of the organization.
- Ability to communicate and work effectively within
sometimes with minimal supervision
- Ability to organize and follow through with tasks -
- Excels at generating and maintaining organized and
and spreadsheet skills.
- Pilgrim Software, MS Office, strong word processing
Division/Department : Insulet Corporation