Quality Assurance Manager
Required skills
- Quality Assurance
- Manufacturing
- Zero Defects
- Inspection Requirements
- Master Control Plans
- Document Control
- Calibration System
- Gauges
- Engineering Change Notice
- First Article Reports
Nice to have
- GMP
Role summary
This Quality Assurance Manager role supports Texas Injection Molding manufacturing by defining, developing, and deploying quality assurance systems and procedures to achieve zero defects. Responsibilities include managing new projects, establishing inspection requirements, documenting control plans, overseeing document control, managing calibration systems, and handling Engineering Change Notices. The role also involves completing First Article Reports, Certificates of Compliance, and providing technical support for corrective actions. Key duties include developing quality metrics, reconciling MRB parts, driving continuous improvement, auditing ISO systems, and training quality department staff. A technical degree or equivalent experience and a minimum of 5 years in manufacturing quality management are required, with 3 years specifically in quality system implementation (e.g., ISO9000, GMP). Proficiency in SPC, engineering drawings, and IQMS is essential.
Description
Position Purpose: To support our customers and Texas Injection Molding manufacturing through definition, development and deployment of company quality assurance systems and procedures with goal of zero defects on all shipped product.
Job Responsibilities:
- Responsible for reviewing new projects and working with customer and engineering team to establish inspection requirements for all parts.
- Works as a liasion between Quality and Engineering Department to properly document and maintain Master Control Plans (MCP) and takes part in Sales and Engineering Review Meetings
- Responsible for document control of customer supplied drawings.
- Responsible for calibration system and control of all gauges and tools used to measure parts.
- Must be proficient and capable of utilizing all gauges, tools, and devices within the quality department.
- Responsible for Engineering Change Notice (ECN) process and insuring we have the latest revision documents
- Responsible for completing any First Article Reports, Customer Approval Forms and maintaining inventory of FAI parts, production samples and customer samples.
- Responsible for ensuring inspection documents are setup and maintained in IQMS.
- Understand and review BOM requirements
- Responsible for completion and maintaining Certificates of Compliance required by customer
- Responsible for providing technical support for NCR and CR actions including driving metrics, root cause analysis and corrective actions for internal quality problems or customer complaints.
- Develop and maintain quality assurance metrics for performance improvement of all teams.
- Support entry of production reporting from shifts 1-3, responsible for reconciling MRB parts within IQMS.
- Drives continuous improvement across all departments
- Responsible for maintaining a clean and orderly work area
- Establishes, implements and audits company ISO System along with outside regulatory certifications.
- Establish and document work instructions for critical task within the company.
- Maintain quality control lab, safety and 5S housekeeping.
- Responsible for the training and technical aptitude of all employees in the quality department.
Requirements
Qualifications
Education:
- 4 year college degree in technical discipline or equivalent experience
Work Experience:
- Minimum of 5 years experience in Manufacturing environment including but not limited to quality management.
- Minimum of 3 years experience defining or leading quality system implementation, development or utilizing such as ISO9000 or GMP
Knowledge/Skills and Abilities:
- A positive can-do attitude
- Understanding of ISO standards and company systems and procedures
- Proficient in quality control testing including calibration, internal audits, document control, trace-ability)
- Statistical Process Control (SPC) tools and data analysis
- Proficient in Microsoft Office
- Good interpersonal skills both written and verbal
- Ability to make timely fact-based decisions; shows good judgment
- Proficient in the ability to read and interpret Engineering Drawings
- Ability to work independently and handle projects to completion
- Ability to oversee and drive quality improvement projects
Performance Metrics
- Internal Scrap % (IPPM)
- External Scrap % (EPPM)
- Meeting Quality System Standards and Ability to Exceed Customer/ISO Audit Requirements
- Customer Feedback
- NCR/CAR Performance
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