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Cretex Medical Component and Device Technologies · 5 hours ago

Quality Inspector

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. The Quality Inspector will perform inspections of components and assemblies, review final release documentation, and ensure compliance with quality plans and GMP guidelines.
Medical Device
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Responsibilities

Perform first piece, in-process inspections, and final inspections of components and assemblies per control/quality plans
Review and approve final release documentation
Perform incoming inspections per control/quality plans for received materials
Complete appropriate quality records within company and GMP guidelines, policies and procedures
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
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

Qualification

CMMISO 9001/13485Quality training/certificationsInspection equipmentMicrosoft OfficeMechanical aptitudeDexterityHand-eye coordinationAttention to detailProblem-solving skillsEffective communication skills

Required

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
Effective organizational, oral and written communication skills
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
Communicate inspection results with team members
Quickly shift priorities in support of production inspection needs
Maintain an organized work area (5S) to include workstations, equipment, walkways, and locker areas
Support and complies with the company's Quality System, ISO, and medical device requirements
Adhere to all safety policies; includes wearing personal protective equipment when required
Complete all other work duties as assigned
Accurately records and reports hours worked
Participate in the Operational Excellence Program
Read and comply with work instructions, set up sheets, and checklists

Preferred

Knowledge of ISO 9001/13485
Quality training/certifications

Benefits

401k retirement savings plan with a company match contribution
Onsite health clinics
Discretionary holiday bonus program (based on years of service)
Cretex University
24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost
Wellness program with incentives
Employee death benefit
Employee sick and safe leave
Comprehensive medical insurance with access to virtual providers
Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)
Vision insurance
Pre-tax health savings account
Healthcare and dependent care pre-tax reimbursement accounts
Paid holidays
Paid time off
Discretionary profit sharing program
Parental Leave
Accident and critical illness benefits
Optional employee, spouse, and child life
Short and long term disability
Company provided life insurance
Tuition assistance programs

Company

Cretex Medical Component and Device Technologies

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Our mission is to make it easier for our customers to get their products to the patients who need them.

Funding

Current Stage
Late Stage
Company data provided by crunchbase