Job Description:Position overview:|
This position works with Program Management, Engineering
and others as the Quality representative on new design
and development projects to ensure new projects meet the
regulatory and quality requirements for medical devices.
Understanding and effectively communicating design and
development regulations, optimizing development, review
and/or approval of design documents and protocols and
ensuring ambiguities and conflicting requirements are
resolved are critical to the success of the position.
JOB / DUTIES / RESPONSIBILITIES
product development activities incorporating global
- Assist design and development teams with realizing new
regulatory requirements and standards. Collaborate with
design team to develop appropriate Design History File
documents. Review and approve new product documentation
validation protocols, review and approve protocols.
- Assist in the development of verification and
- Serve as the Design Control expert on design teams
- Develop and deliver Design control training for design
- All other duties as assigned
Knowledge / Education
systems/ or quality management curriculum or equivalent
- BS degree, in an engineering/scientific/computer
experience. Masters degree preferred
(FDA 21 CFR Part 820) and ISO 13485 quality system
- Working knowledge of the Quality System Regulation
Word, Excel, Access, PowerPoint)
- Working knowledge of Microsoft Office programs (e.g.
specifically in the Medical Device Industry.
- Minimum of 5 years working with development teams,
effective Design Control Systems.
- Experience in the development and implementation of
large documentation sets
- Demonstrated experience organizing and maintaining
- Ability to follow up with task owners to close out
- Good written and verbal communication skills
- Familiarity with structured phase-gate product
- Familiarity with FDA, ISO, and other international
Skills / Competencies
individuals at multiple levels in an organization.
- Effective verbal and written communication skills.
- Experience collaborating and communicate with
- Ability to organize and judge priorities.
- Ability to generate and maintain accurate records.
Division/Department : Insulet Corporation
- Ability to lift up to 20 pounds.