Quality Investigator

SCN BestCo•Santa Cruz, CA

1d•$66,981 - $100,471•Onsite

About The Position

The Quality Investigator plays a pivotal role in leading technical investigations, root cause analyses, and deviation management across regulated environments such as dietary supplements and food. This role supports product release, complaint handling, and risk mitigation by collaborating with cross-functional teams and applying process improvement tools in alignment with FDA and current good manufacturing practice (cGMP) standards. The investigator develops and maintains documentation, trending analyses, and corrective and preventive actions (CAPAs) while driving continuous improvement initiatives. This position also serves as a key liaison for customer-facing quality issues, ensuring thorough and timely resolution. Overall, the Quality Investigator ensures safe, compliant, and high-quality products by maintaining a data-driven, system-oriented approach to quality management.

Requirements

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. Must be able to demonstrate practical problem solving and trouble shooting skills. 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.

Nice To Haves

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).

Responsibilities

Conduct root cause analyses and investigations by leading in-depth assessments of batch deviations, process failures, complaints, and food safety concerns, ensuring thorough root-cause identification and resolution.
Develop CAPAs by implementing quick and effective solutions to eliminate recurring quality issues, verifying CAPA effectiveness through structured analysis.
Oversee customer complaint resolution and analysis including complaint investigations, communication of findings professionally, and driving continuous improvement initiatives to enhance customer satisfaction.
Upkeep regulatory compliance & documentation by ensuring that the investigations align with FDA, cGMP, HACCP, FSMA, ISO, and industry regulations, maintaining audit readiness and reporting accuracy.
Ensure food safety and risk mitigation by overseeing environmental monitoring, performing investigations for failures, assessing product implication, and ensuring adherence to food safety protocols.
Conduct data trending and reporting by analyzing, trending, and presenting quality data using spreadsheets, graphs, and databases, identifying patterns that inform decision-making.
Support process improvement and engineering by utilizing Six Sigma, DMAIC, statistical process control, and design of experiment tools to drive systematic problem-solving and efficiency.
Collaborate cross-functionally, working with Production, R&D, Maintenance, Supply Chain, and Engineering to resolve quality concerns, ensure batch integrity, and optimize product processes.
Oversee standard operating procedures (SOPs) including developing, refining, and maintaining SOPs related to investigations, complaints, and deviation protocols, ensuring consistency in execution.
Run change control and quality assurance initiations, which include product modifications, equipment updates, and procedural shifts, ensuring no negative impact.
Share training and knowledge by guiding team members, conducting internal training, and ensuring team members are proficient in investigation methods and compliance standards.
Lead continuous improvement including identifying efficiency gains, defect reduction strategies, and customer satisfaction enhancements, ensuring that investigation processes evolve and remain effective.