Position: Quality Control Inspector
Locations: Colorado Springs, CO 80921
Duration – 11+ months Contract (Possible extension)
Job Code - PHHJP00007349
In the area of Receiving Inspection, a Quality Inspector III is a senior level inspector position. Responsibilities include but are not limited to performing a wide range of inspection, testing, and auditing in support of Manufacturing Operations and New Product Development. This requires thorough knowledge of Geometric Dimensioning and Tolerancing, Quality System Regulations, various inspection methods, metrology and calibration fundamentals, sampling principals, and fundamental statistical methods. Inspector is required to perform inspections of parts and sub-assemblies, using extremely close tolerances and complex inspection techniques and equipment.
Quality III Inspectors are required to understand and complete necessary updates to Standard Operating Procedures and Work Instructions utilizing a computer based documentation system to implement change orders. Inspector will have advanced knowledge and training abilities in Receiving Inspection, Laser Quality Control, and Catheter Quality Control. Responsibilities also include identifying and contributing to continuous improvement opportunities. Teammate should promote a team environment, demonstrating our Company Shared Values of Innovate, Serve, Win, Own It, Right Things Right Now, Together, and Humility. Quality III Inspectors must maintain and promote a high level of quality standards, productivity, and effectivity meet customer needs.
Qualifications / Responsibilities:
• Ability to read, analyze, and interpret engineering drawings, product specifications, receiving inspection plans, and test procedures.
• Perform visual, dimensional, and functional inspections on consumable products, laser systems, subassemblies, fixtures, and raw material.
• Understand and inspect mechanical assemblies and electronic circuits.
• Understand and utilize Zero Acceptance Sampling Plans using AQL sampling and 100% inspection.
• Through knowledge and understanding of Geometric Dimensioning and Tolerancing (GD&T) and inspection techniques.
• Proficiency with the utilization and programming of coordinate measuring machine (CMM).
• Utilize and train others to use various measuring equipment to determine component acceptance.
• Perform complex First Article Inspections; gathering data and submitting reports.
• Review DHRs and LHRs for Good Documentation Practices.
• Interface with Engineering, Quality, and Production Teammates to communicate quality standards and address issues in a timely manner.
• Prepare area and participate in internal and external quality audits.
• Accurately train inspectors in Receiving Inspection areas minimizing quality mistakes.
• Control nonconforming material and assist in release of quarantine product; which includes: creating, verifying, and closing nonconforming reports.
• Able to draft and generate SOP changes a using web based documentation system.
• Identify improvement opportunities and give input to procedure and process updates.
• Successfully work in and promote a team oriented environment; reduce work area distractions.
Equipment and Systems Used:
• Video micrometer
• Pin gauges
• Surface height indicator
• Digital and manual calipers
• Optical comparator
• Video inspection system
• Laser energy meters
• Optical alignment fixtures
• MicroVu CMM (Coordinate Measuring Machine)
• OGP CMM
• Instron pull test equipment
• Digital multi-function meters
• Computer based Learning System
• Agile documentation system
• Oracle Applications
Education / Skills:
• High School diploma or equivalent required
• Minimum 5 years’ experience in medical device Quality Control Inspection
• Ability to lift and work with parts or sub-assemblies weighing up to 50lbs
• Strong computer abilities; web based systems, Microsoft Office, Material and Document Control Software
• Excellent training abilities and skill
• IPC 610 and IPC 620 Certifications (desired)
• Functional & Technical Skills – Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, and product.
• Customer Focus – Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Action Oriented- Enjoys working hard, is action oriented and full of energy, seizes more opportunities than others.
• Informing – Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides individuals information so that they can make accurate decisions; is timely with information.
• Teamwork- Creates a climate in which people want to do their best; works cooperatively and collaboratively with others to achieve collective goals.
1. Associates Degree in a technical field is a plus
2. Cleanroom or Controlled Environment Experience
3. Government Regulated Environment experience such as FDA, FAA or ISO
Thanks & Regards,
Sr. Technical Recruiter
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark , CA 94560