Quality Inspector - 2nd shift
Cretex Medical Component and Device Technologies
Summary
The Quality Inspector performs first piece, in-process inspections, and final inspections of components and assemblies per control/quality plans. The Quality Inspector will review and approve final release documentation. Performs incoming inspections per control/quality plans for received materials. This role will also complete appropriate quality records within company and GMP guidelines, policies and procedures.
Job description
Position Summary
The Quality Inspector performs first piece, in-process inspections, and final inspections of components and assemblies per control/quality plans. The Quality Inspector will review and approve final release documentation. Performs incoming inspections per control/quality plans for received materials. This role will also complete appropriate quality records within company and GMP guidelines, policies and procedures.
Responsibilities
- Inspection of injection molded parts relating to quality, appearance and performance
- Inspection of assemblies relating to quality, appearance and performance
- Inspection of received materials relating to quality, appearance and performance
- Inspection and audit of final product documentation prior to release
- Determine reasons for defects
- Read and understand quality control plans, blueprints and specifications
- Check parts dimensionally by using precision testing equipment, including Tool Scope, CMM, OGP and various other metrology tools and equipment
- Effective organizational, oral and written communication skills
- Read and comply with work instructions, set up sheets, and checklists
- Accurately records and reports hours worked
- Maintain an organized work area (5S) to include workstations, equipment, walkways, and locker areas
- Participate in the Operational Excellence Program
- Understand and comply with the Cretex professional competencies, company policies, and employee manual
- Adhere to all safety policies; includes wearing personal protective equipment when required
- Support and complies with the company's Quality System, ISO, and medical device requirements
- Complete all other work duties as assigned
Qualifications
- Basic knowledge of inspection equipment use and maintenance
- Read and comprehend customer supplied drawings and specifications
- Communicate inspection results with team members
- Manage multiple requirements and deadlines
- Quickly shift priorities in support of production inspection needs
- High school diploma or equivalent degree (GED)
- Experience with measuring instruments, methods and practices including hand tools and machine devices including CMM and Vision Systems
- Basic knowledge of Microsoft Office (Outlook, Word, Excel)
- Ability to read, comprehend, follow and document work instructions, standard operating procedures, and training documents
- Mechanical aptitude
- Dexterity and hand and eye coordination
- Attention to detail
- Strong problem-solving skills
- Ability to prioritize work and manage multiple tasks
Preferred Knowledge, Skills and Abilities
- Knowledge of ISO 9001/13485
- Quality training/certifications
Requirements
- Basic knowledge of inspection equipment use and maintenance
- Read and comprehend customer supplied drawings and specifications
- Communicate inspection results with team members
- Manage multiple requirements and deadlines
- Quickly shift priorities in support of production inspection needs
- High school diploma or equivalent degree (GED)
- Experience with measuring instruments, methods and practices including hand tools and machine devices including CMM and Vision Systems
- Basic knowledge of Microsoft Office (Outlook, Word, Excel)
- Ability to read, comprehend, follow and document work instructions, standard operating procedures, and training documents
- Mechanical aptitude
- Dexterity and hand and eye coordination
- Attention to detail
- Strong problem-solving skills
- Ability to prioritize work and manage multiple tasks
Benefits
- 401(k) Matching
- Onsite Health Clinics
- Discretionary Holiday Bonus
- Cretex University
- Employee Assistance Program
- Wellness Program
- Employee Death Benefit
- Sick and Safe Leave
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account
- Paid Holidays
- Paid Time Off
- Profit Sharing
- Parental Leave
- Accident & Critical Illness Benefits
- Life Insurance
- Short & Long Term Disability
- Tuition Assistance
- Shift Differential
Company overview
Cretex Medical Component and Device Technologies is a specialized medical device manufacturing company that focuses on producing precision components and complete device assemblies for the healthcare industry. The company operates as a contract manufacturer and supplier of critical medical components, serving original equipment manufacturers (OEMs) in various medical sectors. Their expertise lies in manufacturing complex medical device components that require high precision, strict quality control, and compliance with rigorous medical standards. The company's capabilities typically include injection molding, machining, assembly, and finishing processes for medical devices. They work with a range of materials suitable for medical applications, including various plastics, metals, and biocompatible materials. As a medical device component manufacturer, Cretex plays a crucial role in the medical device supply chain by providing OEMs with reliable, high-quality components that meet regulatory requirements for safety and efficacy. Their services help medical device companies bring innovative healthcare solutions to market while maintaining cost-effectiveness and manufacturing excellence.