Position Summary:
Manage the personnel, material resources, and operations of the Reagents Incoming Quality Control department to ensure compliance with all regulations, quality systems, internal and external customer requirements. Develop, implement, and monitor the performance of Quality Control processes, personnel, and testing methods to ensure reagents continue to conform to the same. Provide coaching, feedback, guidance, and training to employees, ensuring and engaged and skilled staff.
Main Accountabilities:
- Develop and maintain quality performance metrics to provide management a method of assessing the effectiveness of production processes, current specifications, test methods, and personnel performance.
- Manage incoming inspections, in-process inspections, and analytical/physical testing of materials. Support the production of Micro-Use Test cards to test incoming materials.
- Develop and implement inspection, physical/analytical testing, and operational procedures.
- Make recommendations for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate.
- Lead efforts to ensure continuous product and process improvement in areas of responsibility.
- Ensure the quality of Incoming/In-Process materials to maximize the utilization of resources to meet budgetary goals. Ensure timeliness and efficiency of goods and material testing.
- Develop and maintain regular Quality Control trend data and provide periodic reports. Develop and maintain annual departmental budget plans.
- Support review of customer complaints. Participate as needed on special teams and/or projects.
- Monitor and maintain departmental personnel to meet commitments / deadlines. Establish performance criteria, provide training and resources, give regular coaching, feedback and guidance. Ensures an engaged and skilled workforce through active listening and communication.
Knowledge, Experience & Skills:
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A 4-year degree in scientific or technical field with three (3) years progressively responsible experience in a relevant industry (such as medical device) with advanced knowledge of QC chemicals/materials, testing, and inspection procedures.
- High School Diploma/GED with eight (8) years progressively responsible experience in a relevant industry (such as medical device) with advanced knowledge of QC chemicals/materials, testing, and inspection procedure also accepted
- A minimum of one (1) one year experience supervisory experience is highly preferred. At a minimum, must demonstrate the ability to lead others by building relationships, provide coaching and feedback to employees, and delegate assignments as needed to ensure efficient work production.
- Proven excellent verbal and written communication skills are a must as this position interacts at all levels of the organization.
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- Must have a strong knowledge of GMP, ISO, and FDA compliance.
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