Our client, a manufacturer of medical devices, is currently seeking a Quality Control Technician who will be responsible for the daily QC Lab functions, including testing of product, calibration of lab equipment, testing for raw materials and paperwork and process audits.
- Plans and organizes priorities utilizing the Daily Priorities form.
- Responsible for timely achievement of assigned tasks and efficient time management.
- Performs and reports daily testing of product according to established methods and requirements related to raw materials test/inspection/approval/release, final release processes. Supports the in-process testing.
- Manages the testing schedule to support timely deliveries of customer orders.
- Actively participates in the Quality Control Daily Targets related to safety, quality, delivery and cost.
- Evaluates test data to support production and engineering.
- Monitor and report test status of various production runs to QC Manager, Manufacturing Manager, QC Supervisor, Technology, or Process Engineer.
- Identifies out-of-specification materials, including placing product on hold, proper identification and segregation of nonconforming materials, initiating non-conforming material report (NCR) and participating in investigations.
- Provides support to Engineering, IT and R&D including participation in product/process development trials, carrying out new types of raw material and product characterization/performance testing and use of experimental materials.
- Maintains and performs necessary calibrations and re-qualification processes for lab instruments and equipment (ex: densitometers, thermocouples, thermometers, F200s, F100s, PRTs, probes, baths)
- Performs trend analysis of data and makes recommendations for improvements.
- Supports data collection activities by entering information into various databases and spreadsheets.
- Supports/leads calibration program activities to ensure overall Quality Management Process (QMP) compliance.
- Verifies completeness of quality related documentation.
- Assists/performs internal and external audits.
- Maintains and adheres to all company safety policies and procedures.
- Maintains work area organization and documentation to satisfy ISO and GMP standards.
- Maintains good communication and working relationships with all departments and effectively functions within a team environment.
- Exhibits professional etiquette that exemplifies the values of the organization.
- Applies risk-based thinking when evaluating processes performance results for improvement opportunities.
- Drafts/executes change controls, CAPAs, CIs, validation test protocols and prepares required reports.
- Assigned technicians act as a contingency approver for the QC managerial functions such as raw material and interim material (ie manufactured ink) approval and release.
Experience & Skills Required
- Must have a High School Diploma or GED and two to four years related experience and/or training or a combination of equivalent education and experience.
- Experience in an ISO or GMP environment is highly desirable.
- Word processing, spreadsheet (Corel & Excel), e-mail software in a Windows environment; Statistical software (Minitab) a plus.
- Excellent organizational skills.
- Ability to work independently with little supervision.
- Good communication skills, written and oral.
- Ability to read and interpret data, including graphs, as they relate to test results.
- Ability to collect pertinent data, establishes facts, draw conclusions and identify problems.