Sr. QA Tech (temporary to permanent)

 

Position overview:

This position is an integral part of Insulet’s Quality Department. It requires organization and attention to detail while working with other Quality functions to ensure compliance and the accomplishment of departmental and company goals.

 

JOB / DUTIES / RESPONSIBILITIES

• Review applicable DHR’s, NCR’s, CAPA’s, and deviations associated with individual complaints.
• Performs product testing on medical devices (finished goods, sub-assemblies) to ensure FDA, ISO and internal specifications are met.
• Performs metrology inspection using various vision systems (CMM, OGP, etc) and other tools (digital calipers, micrometers, pin gauges, etc) on incoming components.
• Reviews documentation (batch record, CofC or CofA and data) for accuracy, precision and content.
• Generates Non-Conformance Reports once issues on components, documentation or production floor are confirmed.
• Understands and uses SPC and other statistical tools (statgraphics or minitab) and uses these tools to ensure product process parameters are in control.
• Performs data entry for incoming lots and in-process lots.
• Understands GMP and applies this concept on a daily basis.
• Summarize complaint investigations and Root Cause Analysis and drive further action when appropriate.
• Team reference for Pilgrim interface issues.
• Approve / Sign-off work of QA Techs and Jr. QA Techs.
• Provide feedback training concerning write-ups and group lead approvals to drive team improvement.
• Identify and provide updates of work flow issues to immediate manager.
• Gather, evaluate and trending product reliability data.
• Assist the Reliability Engineering staff on special projects.
• Provide leadership to team members and supervisory support including but not limited to training support on procedures.
• Help establish initial FAI methodology on new product development.
• Review help review drawings for completeness and inspect ability.
• Performs Gage R&R studies and First Article Inspections.
• Write Test Protocols and Reports.
• Performs other duties as required.

JOB QUALIFICATIONS

Knowledge / Education

• High School diploma with technical training. AS or BS degree in technical field preferred.

Job Experience

• Minimum of 5 years in a regulated industry (Medical Device Industry preferred).
• Minimum of 5 years in a Quality of manufacturing related function working with QSR and/or ISO 13485.
• Leadership experience required.

Skills / Competencies

• Ability to multitask and learn new material quickly.
• Effective verbal and excellent technical writing skills.
• Ability to communicate and work effectively within the organization.
• Ability to organize and follow through with tasks with minimal supervision.
• Excels at generating and maintaining organized and accurate records.
• Pilgrim Software, MS Office, strong word processing and spreadsheet skills.

Qualified applicants please submit resumes to: careers@insulet.com