Overview 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. Quality Engineer Sr Position Summary 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. 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 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 Quality Engineer Sr Preferred Requirements: Continuing Education; including participation in local chapters, associations, and/or organizations 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. Here are some of things that employees have said about working for Cretex Medical: "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right." "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it." "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives." We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $97,900.00 - USD $122,400.00 /Yr.Company Benefits All Employees: Our 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 are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: 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 are available to employees working 20+ hours/week. 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 are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjU3MDU4LjEwNTA2QGNyZXRleGNvbXAuYXBsaXRyYWsuY29t
