Quality Engineer Sr - NPI

About the role

The Quality Engineer Sr supports the Cretex Medical New Product Introduction (NPI) team, ensuring business growth through quality assurance expertise in a regulated medical device contract manufacturing environment. Key responsibilities include providing quality assurance support for manufacturing, conducting statistical analyses, developing validation reports, and resolving discrepancies.

Responsibilities

• Support NPI project management in a customer-facing capacity
• Perform statistical analysis of data to assess process capability, first article acceptance, and visual inspection
• Create validation reports summarizing validation run results and using data to drive corrective actions
• Develop inspection requirements, facilitate PFMEAs, and resolve discrepant material issues
• Act as the quality interface for NPI teams in responding to customer complaints, using failure analysis, and implementing corrective and preventative actions
• Conduct audits, close out findings, and create audit reports, determining appropriate corrective and preventive actions
• Coach and mentor Quality Engineer levels, I, II, and III
• Lead and participate in large-scale projects, providing quality recommendations
• Partner with sister companies to implement best practices
• Support validation activities, including processes, equipment (IQ/OQ/PQ), and metrology (TMV)
• Ensure business systems are implemented, maintained, and functioning properly
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

Requirements

• Bachelor’s Degree in Mechanical, Industrial, or 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

Preferred Requirements

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

Qualifications

Quality Engineer Sr 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

Pay and Benefits

Pay Range: USD $100,900.00 - USD $151,300.00 /Yr. Company Benefits: 401k retirement savings plan with a company match contribution, onsite health clinics, discretionary holiday bonus program, 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