Quality Engineer Sr

About Cretex Medical

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 the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Position Summary

The Quality Engineer Sr will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

Responsibilities

• Develop inspection requirements; facilitate PFMEAs;
• Resolve discrepant/non-conforming material issues and create and maintain quality documents such as control plans and inspection plans;
• Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis;
• Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions (CAPA);
• Coach and mentor Quality Engineer levels, I, II, and III;
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK;
• Lead and participate in large company-wide projects providing quality recommendations;
• Partner with sister companies to implement best practices;
• Support validation activity of processes, equipment, and metrology;
• Ensure business systems are implemented, maintained, and functioning properly;
• 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.

Qualifications

• Bachelor’s Degree in Mechanical, Industrial, or in another Engineering or Physical Science;
• 10 years of experience in engineering in a molding, assembly or manufacturing setting;
• Knowledge of quality systems, regulatory requirements, and industry standards;
• Ability to consistently achieve short and long-term business results;
• Demonstrate leadership.

Skills

• 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;
• Organizational skills;
• Ability to work in a fast-paced team environment.

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Company Benefits

• All Employees: 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, an employee death benefit, and employee sick and safe leave.
• 20+ hours: 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; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program.
• 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs.

Pay Range

USD $100,900.00 - USD $151,300.00 /Yr.