2 weeks ago

Quality Technician

Insulet Corporation

Waalwijk

2 weeks ago

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Quality Technician

The Post Market Quality Associate at Insulet performs technical tasks related to post market investigations of FDA approved medical devices. The role requires strong organization skills, attention to detail, and the ability to work in cross-functional teams. Preferred candidates have an MBO or Associates Degree in engineering or science, and experience in a regulated industry.

On-siteFull-timeMid LevelMS OfficeExcel

Quality Technician

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On-siteFull-timeMid LevelMS Office

Salary

Not specified

Work Location

Waalwijk, North Brabant, Netherlands, NL

Work Model

On-site

Experience Required

2 years

Employment Type

Full-time

Experience Level

Preferred 2 years in a Quality related function

Core Qualifications

Technical (Must-have)

MS OfficeExcelTechnical WritingQuality SystemsISO 13485FDA RegulationsCAPANCRData AnalysisTrend AnalysisInspectionLot AcceptanceDHRInternal AuditsProcess Evaluation

Soft Skills

OrganizationAttention to DetailCross-functional TeamworkMinimal SupervisionRecord Keeping

Preferred Qualifications

Technical (Nice-to-have)

Electrical BackgroundMechanical BackgroundPareto ChartsBio-hazard/Lab Environment

Key Responsibilities

•Perform moderately complex tasks to ensure compliance with quality standards.
•Determine if materials meet requirements for investigation.
•Execute initial inspection for received material.
•Extract data from returned materials.
•Work with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.
•Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.
•Review Lot Acceptance records and DHRs.
•Perform data logging of quality data and trend results.
•Accountability for quality data entry and productivity.
•Assist in gathering information during FDA and ISO 13485 inspections.
•Perform investigation triage leading to trend analysis supporting existing investigations and CAPA.
•Evaluate process and engineering controls to improve safety and efficiency.
•Perform other duties as assigned.

Quality TechnicianMedical DeviceQuality AssuranceISO 13485FDAOn-siteFull-timeNetherlands

Key Responsibilities

•Perform moderately complex tasks to ensure compliance with quality standards.

•Determine if materials meet requirements for investigation.

•Execute initial inspection for received material.

•Extract data from returned materials.

•Work with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.

•Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.

•Review Lot Acceptance records and DHRs.

•Perform data logging of quality data and trend results.

•Accountability for quality data entry and productivity.

•Assist in gathering information during FDA and ISO 13485 inspections.

•Perform investigation triage leading to trend analysis supporting existing investigations and CAPA.

•Evaluate process and engineering controls to improve safety and efficiency.

•Perform other duties as assigned.