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Company

Original Job Post

BioSpace · 2 days ago

Quality Engineer IV

Dublin, CA

Full-time

Onsite

Senior Level

$148K/yr - $158K/yr

5+ years exp

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Comp. & Benefits

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Responsibilities

Ensure quality standards for manufacturing, servicing, warehousing, & distribution of Zeltiq manufactured products.

Lead & oversee quality operations, drive process improvements, & collaborate with cross-functional teams to maintain compliance & enhance overall quality of the product.

Work in a quality engineering FDA regulated Medical device manufacturing environment.

Serve as quality leader on the production line, providing day-to-day oversight & guidance to manufacturing activities.

Utilize knowledge of QSR & ISO 13485.

Act as primary quality contact for production, ensuring production lines compliance with quality standards.

Review and approve changes made to product and processes, validation/qualification protocols, and reports.

Write reports, data analysis, and business correspondence.

Collaborate with internal customers and suppliers to investigate, document, review, and approve non-conformances, failure analysis reports, and deviations.

Foster effective relationships and integration with other departments and suppliers, collaborating on quality-related activities and initiatives as needed.

Utilize mathematical concepts such as probability and statistical inference to define problems, collect data, establish facts, and draw valid conclusions.

Initiate and update Quality Procedures for Quality Operations functions.

Ensure product compliance with specifications through the implementation of inspection criteria, procedures, and training.

Perform duties in compliance with FDAs Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.

Establish and maintain quality metrics to monitor performance and identify areas for improvement.

Identify and lead projects and initiatives aimed at enhancing the quality system and driving continuous improvement across the production line.

Coach and develop junior team members.

Conduct internal audits to assess compliance with quality standards.

Qualification

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Quality EngineeringFDA RegulationsMedical Device ManufacturingReport WritingData AnalysisBusiness CorrespondenceMathematical ConceptsProbabilityStatistical InferenceData CollectionComplianceRegulatory RequirementsISO13485Canadian Medical Device Regulations

Required

Must possess a Bachelors degree or foreign academic equivalent in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Chemical Engineering, or a related field of study with 5 years of related experience.

In the alternative, employer will accept a Masters degree in aforementioned fields with 1 year of related experience.

Each alternative must possess at least 1 year of experience in the following: working in a quality engineering FDA regulated Medical device manufacturing environment; writing reports, data analysis, and business correspondence; utilizing mathematical concepts such as probability and statistical inference to define problems, collect data, establish facts, and draw valid conclusions; & performing duties in compliance with FDAs Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.