Quality Investigator
$66,981–$100,471 year
On-siteSanta Cruz, California, United States
Job Summary
Conduct root cause analyses and investigations for batch deviations, process failures, and food safety concerns, ensuring thorough identification and resolution. Develop corrective and preventive actions (CAPAs) by implementing effective solutions and verifying their effectiveness through structured analysis. Oversee customer complaint resolution, including investigations and professional communication of findings to drive continuous improvement. Maintain regulatory compliance and documentation by aligning investigations with FDA, cGMP, HACCP, FSMA, and ISO standards while ensuring audit readiness. Analyze and trend quality data using spreadsheets and databases to identify patterns informing decision-making. Collaborate cross-functionally with Production, R&D, and Engineering to resolve quality concerns and optimize processes. Oversee standard operating procedures and quality assurance initiatives, including change controls for product modifications and equipment updates. Share training and knowledge to guide team members on investigation methods and compliance standards. Lead continuous improvement efforts by identifying efficiency gains and defect reduction strategies.
Required Qualifications
- Bachelor's degree in food science, engineering, or related field
- 3 years' professional experience in investigations, engineering, or related function in Quality Control or Assurance in the nutraceutical, pharmaceutical, food, or medical device industry
- Experience with Lean, Six Sigma, QC/QA methodologies, tools, and processes
- Experience working with FDA drug regulations
- Proficiency with Root Cause Analysis (RCA) and Corrective & Preventive Actions (CAPAs)
- Proficiency in Microsoft Office including advanced Excel skills
- Ability to work under pressure in a fast-paced team oriented, ever-changing manufacturing environment
- Ability to apply critical thinking in problem solving
- Ability to demonstrate practical problem solving and trouble shooting skills
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
- Strong communication, organization, and prioritization skills
- Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Ability to write reports, business correspondence, and procedure manuals
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Desired Qualifications
- Master's degree in engineering or related field
- Experience in Quality Improvement and/or Engineering Project Management or similar role in the nutraceutical, pharmaceutical, food or medical device industry
- ASQ Certified Quality Engineer (CQE) and/or Lean Certification Six Sigma Black Belt
- Proficient in statistical analysis software (Minitab, etc)
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