Job Title: QA Acceptance Inspector
Location: Woodinville, WA (Onsite)
Job Summary:
- We are seeking a detail-oriented and team-focused QA Acceptance Inspector to oversee and execute quality assurance activities in support of our medical device operations. This role is responsible for conducting inspections, resolving quality concerns, and ensuring compliance with regulatory standards. The ideal candidate will bring hands-on experience in QA/QC processes and a deep understanding of industry standards and regulations.
Job Responsibilities:
- Conduct daily management of quality concerns and ensure efficient communication and resolution.
- Coordinate daily tasks and track departmental metrics to ensure adherence to quality standards and regulatory requirements.
- Prepare documentation for nonconforming materials from failed inspections or final release activities.
- Interact with stakeholders to resolve discrepancies and deviations, ensuring prompt and accurate documentation of quality issues.
- Perform incoming inspection and final release acceptance activities within the warehouse.
- Create nonconforming material records for failed acceptance activities.
Skills Required:
- Team-oriented mindset with the ability to recognize problems, take action, and provide feedback.
- Detail-oriented with the ability to handle multiple tasks.
- Experience with Test Method Validations (TMV) and measuring equipment.
- Knowledge of Quality Assurance (QA), Quality Management Systems (QMS), and Quality Control Inspection.
- Experience with SAP (MRP/ERP) and understanding of drawing requirements and tolerances.
- Minimum of 3 years of experience in the medical device industry and a basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and EU MDR.
- High School Diploma or Vocational Education.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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