Duties & Responsibilities:
- Perform Receiving, In-Process, and Final inspections of product per AP (acceptance procedure) documents;
- Generate and complete Quality Reports in accordance with released acceptance procedures, drawings, bill of materials, assembly master records, and device master records requirements;
- Perform functional testing per AP (acceptance procedures) and DR (drawing) requirements.
- Release / approval of product labels
- Review of work / job orders for compliance to internal documentation such as AMR (assembly master records), DMR (device master records), DR (drawings), and MB (bill of materials);
- Identification, segregation, and NCR generation for nonconforming products and materials;
- Keep up to date with document revision changes as they affect inspections;
- Movement of material to designated locations in support of inspections, MRB, RMA, and Inventory processes. The material handling will include but not be limited to the physical movement of material in the warehouse and/or QC Areas, use of pallet jacks, packing and unpacking of material, palletizing material, lifting material, and verification of material quantities and documents;
- Perform other duties or special projects as assigned.
- Learning on the job.
- Other duties that may be assigned from time to time.
Minimum Qualifications:
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- PC literate with good skills in MS Office (Word and Excel) programs
- Working knowledge of GDP (Good Documentation Practices)
- Good verbal and written communication skills
- Must be able to work with and without supervision.
- Knowledge on Document management.
- Language: Must speak and write English well.
Preferred Qualifications:
- Prior experience with quality control systems
- Familiar with Part 820 Quality Systems Regulation.
- Familiar with ISO 13485 Standards.
- Familiar with GMP (Good Manufacturing Practices);
- Familiar with Agile, and Expandable ERP systems
- Expertise of manages of Bill of Material.
- 1 year experience within the Medical Device industry.
Education:
Diploma. Professional Cert is an added advantage.