Quality Engineer II

About the Company

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in injection molding, laser processing, metal stamping, and device assembly. Learn more at www.cretexmedical.com.

About the Role

The Quality Engineer II will provide quality assurance support for manufacturing, focusing on the definition, implementation, and improvement of quality-related practices. This role includes technical guidance and measurement methodologies support.

Responsibilities

• Provide quality engineering support for manufacturing and project management
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues
• Create and maintain quality documents such as control plans and inspection plans
• Analyze data and identify improvement opportunities
• Act as the quality interface for production teams in responding to customer complaints using failure analysis, corrective and preventative actions, and trend analysis
• Conduct audits, including closing out audit findings, creating audit reports, and determining corrective and preventative actions
• Lead and participate in intermediate company projects, providing quality recommendations
• Support validation activity of processes, equipment, and metrology
• Create protocols and analyze data
• Support Quality Inspectors to ensure inspection plans comply with customer product requirements
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets served
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other assigned work duties
• Work in a manufacturing environment

Requirements

• Bachelor’s Degree in Mechanical, Industrial, or another Engineering Science
• 3 years of experience in engineering in a machining or manufacturing setting
• Knowledge of quality systems, regulatory requirements, and industry standards
• Intermediate knowledge of blueprint reading and GD&T
• Ability to operate a variety of inspection equipment
• Statistical expertise with DOE and Capability Studies
• Experience with design software such as Minitab
• Process management skills
• Ability to consistently achieve short and long-term business results
• Experience with ERP and quality systems
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail and strong organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask

Work Environment

Cretex Medical offers a positive work environment with a focus on continuous improvement. Employees have shared that the culture is collaborative, with a strong emphasis on teamwork and support across all levels. The company values performance and provides opportunities for growth, safety, and security.

Pay

USD $75,000.00 - USD $112,600.00 per year. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions.

Benefits

• All Employees:
  • 401k retirement savings plan with company match
  • 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
• 20+ hours per week:
  • Comprehensive medical insurance with access to virtual providers
  • Dental insurance (Little Partners Dental benefit covers services 100% 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 and paid time off
  • Discretionary profit-sharing program
• 30+ hours per week:
  • Parental Leave
  • Accident and critical illness benefits
  • Optional employee, spouse, and child life insurance
  • Short and long-term disability
  • Company-provided life insurance
  • Tuition assistance programs

Some benefits are subject to eligibility criteria.