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Zyris

QA Analyst

Quality Assurance – Santa Barbara, California
Department Quality Assurance
Employment Type Exempt
Minimum Experience Experienced

Summary/Objective 

A QA Analyst is responsible for providing support to Quality Assurance, Regulatory Affairs, Engineering, and Production. The QA Analyst will monitor and analyze post market data to perform trend analysis and opportunities for improvement. In addition, this position pursues improved operational effectiveness through the analysis of data relevant to the quality management system.

Essential Functions

Analyze data to monitor status of quality metrics and identify areas for improvement in the quality system

  • Coordinates and monitors Post Market Surveillance data (Complaints, Repairs) for trend analysis and opportunities for improvement.
  • Coordinates and monitors in process quality data (Yields, NCRs, CAPAs, SCARs, and vendor performance) for trend analysis and opportunities for improvement.
  • Participates in the Quality Improvement Team to drive continual improvement of the quality management system.
  • Leverages various software programs such as eQMS, Word, Excel, ERP system, and other necessary programs or project tools to manage and analyze data and complete work.

Risk Management/CAPA

  • Identifies and mitigates quality risks using various sources including FMEA, Post Market data and vendor performance.
  • Provides key oversight to root cause analysis and effective CAPAs throughout the facility.

Prepare reports by collecting, analyzing, and summarizing data; making recommendations

  • Reviews Post Market Surveillance and Clinical data to support Regulatory Submissions.
  • Provides analysis and interpretation of report data to other departments for data driven decision making.

Perform other functions to support company interests

  • Complete daily and weekly activities according to assigned priority, as directed by Director of QA.

Company Values

  • Customer Obsessed
  • Clear Communicators
  • Fact Driven
  • Accountable
  • Deliver Results
  • Committed to doing the Right Thing
  • Innovators

Employee Traits We Value

  • Hungry Learner
  • Humble Expert
  • “On It?” Mindset
  • Adaptability
  • Grit
  • Not emotionally Expensive

Supervisory Responsibility

This position is an individual contributor role.

Education and Experience

  • Bachelor’s degree (B.S.) from a four-year college or university is required.
  • Three to five years of experience in a medical device manufacturing environment is preferred.
  • Expert level proficiency with Excel including the use of pivot tables, conditional formatting, vlookup, and charting (Arrays, Macros, Statistical Functions, etc. a bonus)
Thank You
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  • Location
    Santa Barbara, California
  • Department
    Quality Assurance
  • Employment Type
    Exempt
  • Minimum Experience
    Experienced
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