Quality Control Inspection & Complaint Investigation Specialist
Medical Device Distribution Company
Job Description
Job Description
Role Summary
The Quality Control Inspection & Complaint Investigation Specialist is responsible for performing incoming and final quality control inspections of veterinary products and supporting complaint investigations, corrective and preventive actions (CAPAs), supplier quality activities, and quality system processes. The position combines hands-on product inspection responsibilities with structured quality investigations to ensure products consistently meet established specifications, regulatory requirements, and customer expectations.
This role requires professional industry experience evaluating product conformance through visual, dimensional, functional, packaging, labeling, and specification-based inspections, as well as experience supporting complaint handling and CAPA processes within a regulated quality management system. The specialist serves as a key contributor to product quality, supplier quality oversight, customer satisfaction, regulatory compliance, and continuous improvement initiatives.
This position supports regulated veterinary products and is focused on product quality inspection, complaint investigation, supplier quality, and quality system activities. Candidates should possess professional industry experience performing incoming, final, dimensional, visual, functional, packaging, labeling, or product conformance inspections within a regulated manufacturing or distribution environment.
Experience limited to academic laboratories, research laboratories, microbiology testing, analytical testing, food safety, food production, healthcare administration, hospital operations, patient care, clinical quality, internships, volunteer activities, or laboratory testing environments without direct product inspection responsibilities may not satisfy the requirements of this position.
Key Responsibilities
Quality Control Inspection Activities
- Perform incoming and final quality control inspections of veterinary products to verify conformance with approved specifications, acceptance criteria, drawings, labeling requirements, and product requirements.
- Conduct visual, dimensional, functional, packaging, labeling, and performance evaluations using approved inspection methods, test procedures, and measurement equipment.
- Accurately document inspection activities and results in accordance with established procedures and Good Documentation Practices (GDP).
- Identify, document, and communicate product nonconformances, defects, discrepancies, and quality concerns.
- Determine product acceptance status based on established specifications, inspection criteria, and quality requirements.
- Maintain inspection records, retained samples, and associated quality documentation in an organized and audit-ready condition.
- Assist in developing, revising, and improving inspection methods, acceptance criteria, quality records, and product specifications.
- Monitor inspection results and identify recurring quality issues, adverse trends, or opportunities for improvement.
Complaint Investigation & Quality Activities
- Document customer complaints, nonconformances, supplier quality issues, CAPAs, and other quality events within the company's quality management and issue-tracking systems.
- Gather and evaluate information from customers, suppliers, and internal departments to support complaint investigations and product assessments.
- Communicate professionally with customers to obtain complaint details, supporting documentation, product samples, and additional information necessary for investigations.
- Conduct or support complaint investigations, product evaluations, and root-cause analysis activities using structured problem-solving methodologies.
- Support CAPA activities, including investigation documentation, root-cause analysis, corrective action implementation, verification activities, and effectiveness reviews.
- Collaborate with Quality, Operations, Purchasing, suppliers, and other functional groups to investigate and resolve quality issues.
- Initiate, track, and follow up on Supplier Corrective Action Requests (SCARs) and supplier investigations to ensure timely and effective resolution.
- Prepare summaries of complaints, CAPAs, nonconformances, supplier quality issues, and quality trends for management review and continuous improvement activities.
- Escalate significant quality concerns, product risks, recurring issues, and adverse trends to management in a timely manner.
Quality System Support
- Follow established quality system procedures, Good Documentation Practices, record retention requirements, and regulatory expectations.
- Support change management activities by documenting, reviewing, and communicating quality-related changes.
- Maintain complete, accurate, and audit-ready quality records.
- Participate in internal audits, training activities, supplier quality initiatives, and continuous improvement projects as assigned.
- Support compliance with applicable company procedures, ISO-based quality management system requirements, and applicable regulatory requirements.
Minimum Qualifications
- Bachelor's degree in Engineering, Physical Sciences, Life Sciences, or a related technical discipline (e.g., Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Chemistry, Biology, or related field).
- At least 3–5 years of quality assurance, quality control, complaint handling, CAPA, supplier quality, or related quality experience within medical device, veterinary product, pharmaceutical, biotechnology, or similarly regulated product manufacturing or distribution environments.
- Minimum 2 years of professional industry experience performing incoming and/or final product inspections in a regulated manufacturing or distribution environment. Experience must include evaluation of product conformance to specifications, drawings, acceptance criteria, inspection criteria, or test methods. Academic, internship, volunteer, and research-only experience will not be considered equivalent.
- At least 2 years of experience supporting complaint investigations, nonconformance investigations, and CAPA activities, including documentation, root-cause analysis, corrective action implementation, and effectiveness verification.
- Experience identifying, documenting, and investigating product nonconformances and quality issues.
- Ability to read, interpret, and apply technical specifications, engineering drawings, inspection criteria, product requirements, and test procedures.
- Strong written communication skills and attention to detail for preparation of inspection reports, investigation records, and quality documentation.
- Experience utilizing structured root-cause analysis methodologies such as 5 Whys, Fishbone (Ishikawa), or similar problem-solving techniques.
- Familiarity with complaint management systems, issue-tracking systems, or similar quality software.
- Experience communicating with customers regarding product quality concerns, complaint investigations, or technical product issues.
- Experience interacting with suppliers regarding product quality concerns, investigations, corrective actions, and Supplier Corrective Action Requests (SCARs).
- Experience supporting change management activities within a regulated quality system.
- Working knowledge of ISO-based quality management systems; familiarity with ISO 13485 is strongly preferred.
- Demonstrated ability to communicate quality issues, trends, and risks effectively to management and cross-functional teams.
Preferred Qualifications
- Experience with veterinary medical devices, medical devices, veterinary products, pharmaceutical products, biotechnology products, or other regulated healthcare-related products.
- Experience conducting dimensional inspections and using measuring equipment such as calipers, micrometers, gauges, force measurement devices, or other inspection equipment.
- Experience reviewing product specifications, drawings, labeling requirements, and acceptance criteria.
- Experience developing drawings utilizing CAD-based applications.
- Experience managing Supplier Corrective Action Requests (SCARs) and supplier quality investigations.
- Experience supporting FDA-regulated quality systems and complaint handling processes.
- Internal audit experience within an ISO-based quality management system.
- Familiarity with risk assessment, CAPA effectiveness verification, and continuous improvement methodologies.
- Mandarin Chinese language skills a plus.
Personal Skills & Competencies
- Detail‐oriented mindset for accurate documentation and inspection work.
- Analytical thinking to support investigations and identify patterns.
- Clear, professional communication skills for customer, supplier, and internal team interaction.
- Professionalism and empathy when handling customer complaints.
- Strong organizational skills to manage multiple open issues and maintain structured, compliant records.
- Technical curiosity and willingness to learn product functionality and failure modes.
- Ability to work collaboratively with quality, engineering, manufacturing, and customer service teams.
- Adaptability in a role that may evolve as the company evaluates market needs.
We are a well-established brand and private label supplier of quality veterinary products working with some of the industry’s largest distributors. We provide a healthy work environment, competitive salaries and attractive working hours; making our company an amazing place to work and grow.
Company Description
We are a well-established brand and private label supplier of quality veterinary products working with some of the industry’s largest distributors. We provide a healthy work environment, competitive salaries and attractive working hours; making our company an amazing place to work and grow.
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