Position Summary
The Quality Investigator is responsible for leading and documenting investigations related to product, process, supplier, customer, and manufacturing quality issues. This role partners cross-functionally with Quality Engineering, Manufacturing, Quality Operations, Regulatory Affairs, Supplier Quality, and Technical Services teams to identify root causes, implement effective corrective and preventive actions (CAPA), and ensure compliance with company procedures and applicable regulatory requirements.
The ideal candidate possesses strong analytical skills, investigation experience, and a thorough understanding of quality systems, risk management, and continuous improvement methodologies.
Key Responsibilities
Quality Investigations
- Lead and document nonconformance, deviation, complaint, CAPA, and quality event investigations.
- Conduct comprehensive root cause analyses using tools such as:
- 5 Whys
- Fishbone (Ishikawa) Diagrams
- Fault Tree Analysis
- Pareto Analysis
- Contradiction Matrix
- Cause and Effect Matrix
- DMAIC methodologies
- Evaluate quality data, manufacturing records, testing results, and process trends to identify potential causes and contributing factors.
- Ensure investigations are completed accurately, thoroughly, and within established timelines.
Corrective and Preventive Actions (CAPA)
- Develop and recommend effective corrective and preventive actions based on investigation findings.
- Collaborate with functional teams to implement CAPAs and verify effectiveness.
- Monitor CAPA progress and ensure timely closure.
Quality Systems Compliance
- Ensure investigations comply with internal quality procedures and applicable regulatory requirements.
- Support internal, customer, and regulatory audits by providing investigation records and evidence of compliance.
- Assist in maintaining inspection readiness and audit preparedness.
Data Analysis & Trending
- Analyze quality metrics and trends to identify recurring issues and systemic risks.
- Generate investigation summaries, management reports, and trend analyses.
- Support continuous improvement initiatives based on quality data insights.
Cross-Functional Collaboration
- Partner with Manufacturing, Engineering, Supply Chain, Supplier Quality, Regulatory Affairs, and Quality Operations teams to resolve quality issues.
- Facilitate investigation meetings and communicate findings to stakeholders.
- Provide guidance on investigation methodologies and documentation best practices.
Continuous Improvement
- Participate in process improvement projects aimed at reducing defects, improving product quality, and increasing operational efficiency.
- Recommend enhancements to quality systems, procedures, and workflows.
- Support lessons-learned activities and knowledge-sharing initiatives.
Qualifications
Education
- Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical field required.
Experience
- Minimum 2 years of experience in Quality Assurance, Quality Engineering, Manufacturing Quality, or Quality Systems.
- Experience conducting investigations and root cause analysis in a regulated or manufacturing environment.
- Experience working with nonconformance, CAPA, complaint, or deviation systems preferred.
Knowledge & Skills
- Strong understanding of quality management systems and quality processes.
- Knowledge of root cause analysis and problem-solving methodologies.
- Experience with electronic quality management systems (eQMS) preferred.
- Strong technical writing and documentation skills.
- Excellent analytical and organizational abilities.
- Proficiency with Microsoft Office applications, including Excel and Power BI preferred.
- Ability to manage multiple investigations simultaneously while meeting deadlines.
- Strong verbal and written communication skills.
Preferred Qualifications
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or related certification.
- Experience in medical device, pharmaceutical, biotechnology, aerospace, automotive, or other regulated industries.
- Familiarity with risk management methodologies and statistical analysis tools.
- Experience with ISO 9001, ISO 13485, FDA QSR, or equivalent quality standards.
Key Performance Indicators (KPIs)
- Investigation closure cycle time.
- On-time completion rate for investigations.
- CAPA effectiveness rate.
- Reduction in recurring quality issues.
- Audit observations related to investigations.
- Quality system compliance metrics.
- Aged investigation backlog reduction.
Competencies
- Critical Thinking
- Attention to Detail
- Problem Solving
- Technical Writing
- Collaboration
- Accountability
- Process Orientation
- Continuous Improvement Mindset
- Integrity and Objectivity
Career Path
Quality Investigator Senior Quality Investigator Quality Engineer / Senior Quality Engineer Quality Engineering Specialist
This position plays a critical role in ensuring product quality, regulatory compliance, and continuous improvement across the organization.
Salary Range- $71,169 - $89,000
