Quality Assurance Specialist
1 week ago
The Quality Inspector plays a crucial role in verifying that products and their components meet established specifications and quality benchmarks. This position involves testing and evaluating products throughout various phases of the manufacturing process to ensure they meet performance and customer integrity standards, thereby guaranteeing product quality and dependability. Each team member is expected to uphold cleanliness and organization within the workspace while adhering to CathX Medical's environmental health and safety policies.
Key Responsibilities:
- Interpret engineering schematics according to ASME Y 5 and GD&T standards, understand standard measurement units and their conversion methods, and accurately document data from instruments onto inspection sheets using Good Documentation Practices (GDP). This role requires complete guidance for daily tasks.
- Select appropriate measurement tools and comprehend the tenfold rule for measurements. Understand the concepts of precision and accuracy in measurement. Proficient in using basic hand measurement instruments such as rulers, calipers, snap gauges, micrometers, pin gauges, microscopes, drop gauges, and timers.
- Choose products for testing at designated stages in the production cycle and assess products for attributes and variable requirements, including visual inspection, dimensional accuracy, performance, and mechanical properties.
- Implement statistical quality control methods, including inspection sampling plans (AQL, C=0, Z1.4, Z1.9).
- Capable of entering data into computer systems for analysis and reporting.
Supervisory Responsibilities:
This position does not entail any supervisory duties.
Qualifications:
- Certification in Quality Inspection from ASQ or equivalent training from Mitutoyo or other recognized technical institutions.
- Familiarity with FDA 21 CFR, part 820 Quality System Regulations.
- Understanding of Good Manufacturing Practices and Good Documentation Practices.
Core Competencies:
To excel in this role, candidates should demonstrate the following competencies:
- Values: Integrity, Accountability, Teamwork, Innovation
- Strong verbal and written communication skills
- Ability to work autonomously
- Capability to manage tight deadlines and shifting priorities
- Analytical mindset with excellent problem-solving skills
- Proficient in Microsoft Office applications
- Ability to generate innovative solutions with meticulous attention to detail
Physical Demands and Work Environment:
The characteristics of the work environment described here are representative of those an employee may encounter while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
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