Position Summary.
The Quality Control Supervisor will be responsible for training personnel and planning, facilitating, and executing QC activities to inspect and test Nuclein’s diagnostic medical devices, subassemblies, and components. The role involves maintaining a high level of quality in the product by ensuring adherence to specifications, applying rigor, technical knowledge and skills to daily operations, and collaborating with team members on investigations. The QC Supervisor has working knowledge of the qc methods, criteria and strategy and the ability to train and develop QC Technicians.
Essential Duties and Responsibilities.
· Supervises, trains, and mentors QC personnel
· Coordinates and deploys QC resources in an efficient manner to meet production schedules
· Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance
· Maintains work area and equipment to GMP standards, performs equipment maintenance and metrology, ordering/receiving supplies
· Performs data analysis, records results, approve results, and archives quality records
· Understands the Quality Control strategy
· Recognizes and reports deviations, non-conformances, and out of specification events promptly and accurately, performs material quarantine
· Initiates Nonconformance (NC) with appropriate information, assists with investigations and resolves NCs as assigned
· Reviews quality records for completeness, accuracy, and compliance, resolves discrepancies
· Leads work instructions creation/revision, supports test method development and continuous improvement efforts as assigned
· May participate in validation activities
· May support quality audits
Education, Qualifications, and/or Experience.
· Associate’s degree or higher in a technical discipline or equivalent work experience
· Minimum 4 years QC work experience required, 2+ years in medical device or other regulated industry required
· Previous supervisory experience preferred
· Quality certification, such as ASQ CQI, CQT or ASME GD&T preferred
· Strong computer skills and experience with laboratory equipment
· Strong attention to detail and problem solving skills
· Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance
· Proficiency reviewing records for completeness and accuracy
· Strong organizational and time management skills
Physical Requirements.
· Repetitive Motion: Picking and placing parts, use of laboratory equipment, computer use
· Weight Lifting: < 50 lbs
· Position: Sitting and standing
· Speaking and communicating
· Use of PPE may be required in laboratory/manufacturing/warehouse areas
LOCAL CANDIDATES ONLY - SPONSORSHIP IS NOT OFFERED AT THIS TIME
| Location | Austin, TX |
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