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Senior Quality Investigation Engineer
Johnson & JohnsonSenior Product Quality Investigation Engineer in the healthcare sector leading investigations for quality complaints. Collaborating across global teams to ensure product integrity and compliance.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Product Quality Complaint investigations, complaint management processes, and regulatory compliance within the pharmaceutical and medical device industries. Proficient in risk management, analytical problem-solving, and effective communication across multi-functional teams.
Highest-signal resume keywords
Product Quality Complaint InvestigationQuality AssuranceRegulatory ComplianceRisk ManagementSix Sigma Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Complaint ManagementPost-Market VigilanceFailure Mode AssessmentAnalytical SkillsTechnical Documentation
Soft Skills
Problem-SolvingCollaborationCommunication
Tools & Technologies
Product Quality Management SystemsComplaint DatabaseStandard Operating Procedures
Certifications & Qualifications
Green Belt (Six Sigma)Black Belt (Six Sigma)ASQ Certified Quality Engineer (CQE)
Industry Keywords
Pharmaceutical IndustryMedical Device Industry21 CFR ComplianceISO 13485GMP
About the role
Key responsibilities & impact- Lead, conduct, and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products
- Help ensure investigations are complete, scientifically sound, and appropriately documented within the Product Quality Complaint database
- Evaluate technical information to ensure appropriate analyses, investigations, and failure mode assessments have been performed and documented before complaint closure
- Support Product Quality Vigilance projects, new business initiatives, and complaint management processes
- Serve as a key partner to manufacturing sites and multi-functional teams
- Serve as a key Product Quality Vigilance contact for assigned manufacturing sites, supporting investigation activities, complaint management processes, issue escalation, and product knowledge transfer
- Participate in failure investigations, Medical Device Reporting activities, and product trend evaluations
- Collaborate with Manufacturing Sites, Product Development Managers, Contact Centers, Global Medical Safety, Marketing, Sales Administration, Brand Protection, Engineering Quality, Product Quality Management, and other partners to strengthen investigation activities, share product knowledge, and support complaint handling processes throughout the product lifecycle.
- Create and maintain work instructions and standard operating procedures related to complaint investigations and complaint management activities.
Requirements
What you’ll need- Bachelor’s degree in a technical, scientific, or engineering field required
- Master’s degree, MBA, or other advanced scientific or engineering degree preferred
- Minimum 5 years of experience in Quality Assurance, Quality Control, Product Quality, or a related quality function
- Proven experience within the pharmaceutical, medical device, or another highly regulated industry
- Experience in Complaint Management, Post-Market Vigilance, Risk Management, or Compliance is preferred
- Previous project leadership or supervisory experience is desirable
- Knowledge of medical safety environments and applicable laws
- Experience with complaint investigations, risk management activities, and product quality systems
- Ability to support change initiatives, project activities, and collaboration across functions and sites
- Familiarity with applicable laws and standards, including 21 CFR Parts 4, 210, 211, 314, 803, 806, and 820; ISO 13485; ISO 14971; ICH Q10; GDP; GMP; GVP; MEDEV 2.12; CMDR; and Medical Device Directive 93/42/EEC
- Strong analytical, investigation, and problem-solving skills
- Ability to communicate optimally verbally and in writing
- Ability to present technical information to multiple levels and departments within the organization
- Ability to build strong working relationships in a global environment
- Green Belt (Six Sigma) or equivalent investigation training is desirable
- Black Belt (Six Sigma) and/or ASQ Certified Quality Engineer (CQE) certification is preferred
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity.
Benefits
Comp & perks- an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- employees - and in some location’s eligible dependents - can participate in several insurance plans.