Description
PRIMARY RESPONSIBILITIES:- Performs receiving, in-process and/or final inspection and testing activities.
- Reviews and approves DHR's and other quality related management system documentation.
- Determines product status based upon quality inspection results.
- Assists in the implementation of the quality management system.
- Creates and maintains quality procedures and work instructions and ensures compliance to written requirements.
- Supports on-site document control initiatives and training.
- Participates in the process for the disposition / handling of rejected and expired product.
- Acts as on-site calibration representative to ensure compliance with calibration requirements.
- Responsible for ensuring on-site quality record retention compliance.
- Participates in the PCOR process and facilitates improvement efforts as needed.
- On-site representative for ensuring device labelling compliance, including correct label/packaging revisions.
- Participate in corporate, internal and third party quality audits as required.
- Responsible for providing quality reports including metrics reporting as required.
REQUIRED KNOWLEDGE, SKILLS, and ABILITIES:
- Attention to detail and problem solving skills.
- Knowledge of standard practices in quality assurance, including quality control/inspection.
- Strong computer skills and ability to use Microsoft Office products including Outlook, Word, and Excel.
- Ability to exercise good judgment in evaluating situations and proposing solutions.
- Previous QC/QA experience in medical device or similar industry.