Quality Engineer Sr - NPI

Cretex Medical Component and Device Technologies • Brooklyn Park, MN

1d • $100,900 - $151,300 • Onsite

About The Position

The Quality Engineer Sr will support the Cretex Medical New Product Introduction (NPI) team enabling business growth by providing quality assurance expertise within a regulated medical device contract manufacturing environment. This role is accountable for defining, implementing, and improving quality-related practices, ensuring compliance with industry standards and regulatory requirements. The Quality Engineer 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.

Requirements

• Bachelor’s Degree in Mechanical, Industrial, or in another Engineering or Physical Science
• 10 years of experience in engineering in a machining 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

Nice To Haves

• Continuing Education; including participation in local chapters, associations, and/or organizations

Responsibilities

• Provide Quality Engineering support to NPI project management in a customer-facing capacity
• Perform the statistical analysis of data to assess process capability (Cpk/Ppk), first article acceptance (FAI), and visual inspection
• Create validation reports to summarize the results validation runs and uses data in a manner that compels corrective action where needed
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
• Act as the quality interface for a NPI 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
• 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 (Body of Knowledge)
• 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 (IQ/OQ/PQ), and metrology (TMV).
• 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

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
• a 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees