The Quality Manager plays a pivotal role in managing the various facets of quality control. This includes maintaining essential certifications, handling customer feedback, conducting inspections, machine programming, and participating in audits. The ideal candidate will possess a profound depth of expertise in specialized functions that will be instrumental in shaping policies and developing innovative ways to achieve business goals.
- Oversee, plan, and prioritize workload inspections, First Article Inspections (FAI’s), and Coordinate Measuring Machine (CMM) programming.
- Handle, document, track, and analyze customer feedback, non-conformities, and Corrective And Preventive Actions (CAPA’s).
- Oversee process validations, special requirements capability studies, Gage Repeatability and Reproducibility (R & R), and other statistical studies as required.
- Maintain and manage quality system procedures, forms, work instructions, and ensure adherence to International Organization for Standardization (ISO) 13485 registration.
- Manage calibration systems and gage calibration.
- Supervise Engineering Change Orders (ECO’s), customer revision modifications, and disposition of Work in Process (WIP) and inventory.
- Authorize the Material Review Board (MRB) for item disposition.
- Conduct part inspections and sort customer parts as needed.
- Coordinate internal and external audits; oversee customer audits.
- Administer HR tasks using the Human Resources Information System (HRIS).
- Strategize and organize the department’s work plans, delegate tasks, and review procedures.
- Monitor work systems, evaluate performance, and implement improvements.
- Train, mentor, and assess staff; collaborate on HR matters and address employee performance issues.
- Technical certificate or associate’s degree in programming/process engineering or a related field.
- 8+ years of experience in quality control, inclusive of 3 years in a supervisory role.
- Candidates should possess or be able to pursue Lean training, Black Belt training, and Geometric Dimensioning and Tolerancing (GD&T) training.
Skills & Abilities:
- Comprehensive knowledge in engineering and geometric dimensions and tolerances.
- Proficiency in measuring tools such as calipers, micrometers, depth gages, indicators, and various Go/No Go gages.
- Familiarity with ISO 13485 and FDA 21CFR820; on-the-job training provided.
- Technical prowess in software like Microsoft Office Suite, SolidWorks, metrology software, and ERP systems.
- Skilled in basic mathematics, problem-solving, project prioritization, and creative thinking.
- Capable of fostering teamwork, delegation, and maintaining focus in dynamic work settings.
- Exceptional communication skills in English, both written and oral.
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