Quality Control Inspector Iii - Medical Device Manufacturing

QA Acceptance Inspector:

• Follow assigned procedures and complete all training records.
• Perform incoming inspection and/or final release acceptance activities within warehouse.
• Creation of NCM records for failed acceptance activitiesUnderstand device history records and Bill of Materials (BOM) Partner with warehouse operations, SQ on resolving quality issues.
• Ensure quality system records (DHR, inspection, and other applicable records) are complete, accurate and comply with procedures.
• Completes Inspection planning tasks for incoming inspection documents.
• Meet departmental metrics: Incoming inspection to performance targets NCM/QN to performance targets Training completion to target

• Performs timely incoming inspection and inspection plan creation of purchased finished goods received at the warehouse per established methods.
• Creates timely nonconforming records for failed inspections or final release activities.
• Created inspection plans for incoming inspections and updates work instructions.
• Creates engineering changes and ensures inspection planning requirements are met.
• Responsible to meet departmental metrics.
• Manages daily management board data and may lead meetings.
• Responsible to champion lean initiatives and continuous improvement.
• Escalates issues to direct manager.
• Generates departmental metrics and reports to management.
• Completes work with a limited degree to no direct supervision.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues for direct area of responsibility.
• Likely to act as an informal resource for colleagues with less experience.
• Developed professional expertise, applies company policies and procedures to resolve a variety of issues for direct area of responsibility.
• Has developed specialized skills and is multi-skilled through job related training and considerable on the job training/experience.• organizational, interpersonal skills required.
• Technical writing, communication, and organizational, interpersonal skills required.

REQUIRED COMPETENCES

• Team oriented mindset
• Ability to recognize problems, take action, provide feedback
• Detail oriented
• Ability to deal with multiple tasks.
• Deliver Results
• hold self accountable, acts with urgency and resilience to deliver on commitments
• Drive Operational Excellence
• Collaborate End2End and share knowledge and ideas.
• Commitment to Quality
• Demonstrates understanding of the Quality System requirements

Experience & Background

• Able to complete set-up and inspections with a coordinate measuring machine and other inspection tools as necessary.
• Test Method Validations (TMV) knowledge.
• Past measuring equipment experience.
• First Article experience.
• SAP (MRP/ERP) experience desired.
• Able to read and understand drawing requirements and tolerances.
• 2 years of experience in a Medical Device industry required.
• Prior experience in working in a manufacturing or warehouse related environment, required.
• 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.