Quality Assurance/Quality Control Manager
HWSTAFFING Cranston, RI 02910
- Provide technical guidance to QC personnel.
- Supervise personnel engage in final inspection and testing activities.
- Act as the Management Representative Design within the Bio Detek
- Ensure a high level of external customer service.
- Investigate customer issues and complaints relating to quality.
- Investigate cause and quality problems identified at incoming inspection, manufacturing and final QC inspection.
- Create,document and implement inspection criteria an procedures.
- Provide and oversee inspection activity for product e throughout production cycle.Collect analyze and disseminated quality data throughout the organization.Design develop and implement quality control training programs in Material Review Board a
- Adhere to and ensure compliance with quality systems SOP's work instruction drawings Good Manufacturing Practices ISO and FDA requirements
- Provide support and participate in customer and agency quality audits.
- Develop and implement quality improvement programs.
- Lead department effort in CAPA investigation and completion
- Maintain the Calibration program
- Participate in validation and verification planning activities,including protocol and report review.
- Participate in Engineering Change Order review and approval activities as required
- Other duties as assigned
- Minimum 5-10 years related experience in a regulated environment, preferably medical device,5 years in managerial/supervisor role
- Proficient at problem solving-analytical and diagnostics proficiency.
- Strong communication skills to include presentation capabilities.
- Excellent verbal and written communication skills.
- Experience with ISO 13485 and FDA QSR for medical devices and FDA Quality System.
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