Job Description
Performance and inspection responsibilities listed below.
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. This includes physical movement of material in the warehouse and/or QC Areas, use of pallet jacks, packing and unpacking, palletizing, lifting, 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
- 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 in managing Bill of Material
- 1 year experience within the Medical Device industry
Education
Diploma. Professional Cert is an added advantage.