38 applicants

Company

Original Job Post

Enovis · 3 days ago

Quality Assurance Engineer

Vista, CA

Full-time

Onsite

Mid, Senior Level

5+ years exp

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Responsibilities

Develop, implement, and maintain Master Quality Plan

Facilitate quality improvement through data collection, control charting, and experimental design techniques.

Participate in the Master Validation Plan (IQ, OQ, PQ) for validation processes.

Lead continual improvement activities such as 5S and Kaizen lean methods.

Develop and conduct training programs for quality awareness.

Interface with Engineering and Operations to ensure product changes align with approved data.

Support Quality Inspectors/Techs to ensure compliance with the quality management system.

Conduct audits and analyze failure, corrective, and preventive actions.

Create and maintain company quality documentation.

Organize and manage receiving/outgoing quality functions.

Drive continuous improvements and manage Nonconformances.

Resolve customer and internal quality concerns using problem-solving techniques.

Work on DOE projects and manage Gage R&R, SPC, and Capability requirements.

Participate in Launch and Current Production Engineering Changes.

Support Lean initiatives and review of Daily and Weekly Quality performance Scorecards.

Ensure a safe work environment and compliance with safety and environmental regulations.

Evaluate nonconforming material and recommend updates to quality standards.

Assure product compliance with internal or external specifications and standards.

Analyze trends in device failures and lead root cause analysis.

Support Manufacturing and Operations to resolve quality or compliance issues.

Serve as a subject matter expert for quality in audits.

Author procedures and work instructions for the quality system

Conduct internal audits and support complex special projects as assigned.

Qualification

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Auditing CertificationMedical Device EngineeringFDA/GMP KnowledgeCMDR KnowledgeMDR KnowledgeMDSAP KnowledgeISO Quality Standards KnowledgeManufacturing Processes KnowledgeMicrosoft Word ProficiencyExcel ProficiencyStatistical AnalysisDatabase SearchesQuality System Regulations KnowledgeProject Management SkillsMicrosoftMinitabOracle R12Agile PLMCQELean6 Sigma CertificationBilingualProblem-Solving

Required

Bachelor’s degree in science or engineering and 5 plus years of applicable experience (CQA or CQE certification preferred)

Certification to perform audits is required (certification may be obtained through successful completion of an auditor course or CQA, or on-the-job training by another qualified internal auditor)

Proficiency in Medical Device engineering standards and concepts, along with knowledge of FDA/GMP, CMDR, MDR, MDSAP, and ISO quality standards

Basic knowledge of manufacturing processes (and associated tools, instruments, and test equipment) including inspection, machine shop technology, polish/grind, and clean room technology

Proficient in Microsoft Word (or equivalent word processing software) and Excel (or equivalent spreadsheet software). Statistical analysis and database searches

Competent working knowledge of US and International quality system regulations

Proven project management skills