Sr. Quality Engineer - Molding & Assembly - Cretex Medical Component and Device Technologies

About Cretex Medical

Cretex Medical is a family of companies that provides manufacturing and engineering services to medical device OEMs. 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 Senior Quality Engineer - Molding & Assembly  assumes a vital role within our organization, with a primary focus on delivering comprehensive quality assurance support to our manufacturing processes. This position is instrumental in shaping and executing quality-related practices, with a strong commitment to continuous improvement. As a Senior Quality Engineer, you will also provide essential technical guidance and support in implementing measurement methodologies to ensure the highest standards of quality are consistently met. Additionally, you will champion leadership, mentorship, and ISO 13485 compliance.

Senior Quality Engineer Molding & Assembly Responsibilities:

• Quality Process Development and Control: Lead the creation and maintenance of comprehensive process flow, control plans, inspection requirements, PFMEA’s, and Master Validation Plans for production processes. Continuously monitor these processes to ensure they remain under control and consistently yield high-quality products.
• Customer Complaint Resolution: Act as the primary quality liaison with our customers, leading the charge in addressing customer complaints through extensive failure analysis, corrective and preventive actions, and trend analysis. Establish and nurture quality-focused relationships with our customers to guarantee their specific quality needs are met.
• Measurement Methods and Capability Analysis: Collaborate with our programming and inspection teams to develop robust, repeatable inspection programs and analysis processes, ensuring our capabilities remain at the highest standards.
• Subject Matter Expertise Assembly and Molding: Demonstrate expertise in device assembly and injection molding plastics for both reduction in process variation and enhanced visual and dimensional inspection. 
• Validation Support: Provide essential support for the IQ/OQ/PQ validation of Injection Molding tools, processes, equipment, and metrology to ensure not only compliance but best-in-class performance.
• Quality Standards: Lead the establishment and evolution of robust quality standards and processes to uphold our commitment to delivering top-tier products.
• Process Enhancement: Work closely with cross-functional teams to identify areas for process improvement and drive lean initiatives and operational excellence that enhance product quality.
• Technical Expertise: Provide technical expertise in quality assurance, ensuring that manufacturing processes meet industry standards and regulations, including ISO 13485 compliance for medical devices.
• Quality Auditing: Regularly conduct comprehensive quality audits, evaluating compliance against established quality standards, and providing valuable insights for further enhancements.
• Data Analysis: Analyze quality data to detect trends, potential issues, and areas for optimization. Use data-driven insights to make informed recommendations.
• Root Cause Analysis: Lead investigations into quality issues using CAPA (Corrective and Preventive Action) methods, identifying root causes and orchestrating effective corrective and preventive actions.
• Quality Metrics: Establish and monitor key performance indicators (KPIs) that serve as barometers for quality objectives, ensuring they are met consistently.
• Leadership and Mentorship: Provide leadership in quality initiatives, fostering a culture of excellence and mentorship within the quality assurance team and other departments.
• Supplier Collaboration: Collaborate with suppliers to ensure the quality of incoming materials, conduct supplier audits, and maintain strong relationships that reinforce quality standards.
• Regulatory Compliance: Stay abreast of industry regulations and standards, ensuring our organization's unwavering compliance with pertinent requirements, particularly ISO 13485 and CFR 820 for medical devices.
• Documentation Excellence: Maintain meticulous documentation related to quality assurance processes, audits, and continuous improvement initiatives.

Senior Quality Engineer Molding & Assembly Qualifications:

• Bachelor's or Master's degree in an engineering or related field.
• A proven track record, showcasing a minimum of 10 years of experience in quality engineering, including roles with progressively increasing responsibilities.
• Demonstrated leadership skills that empower you to effectively guide and inspire teams.
• Proficiency in quality management systems and ERP tools, demonstrating your ability to navigate and leverage these systems effectively.
• Strong analytical skills enabling you to identify data patterns and trends crucial for quality improvements.
• Exceptional communication and interpersonal skills that facilitate seamless collaboration with multifunctional teams.
• A comprehensive understanding of industry-specific quality standards and regulatory prerequisites, including familiarity with ISO 13485 for medical devices.
• Adaptability to excel in a fast-paced team environment, showcasing your ability to thrive under pressure.
• Proficiency in Microsoft Office applications, encompassing Outlook, Word, Excel, PowerPoint, and Publisher.
• Any certification in quality management, such as ASQ Certified Quality Engineer, is regarded as a valuable asset that further enhances your qualifications.

Senior Quality Engineer Molding & Assembly Preferred Qualifications:

• A keen eye for detail and exceptional organizational skills, allowing for meticulous and systematic work.
• Strong problem-solving and critical thinking abilities, enabling innovative solutions to complex challenges.
• Leadership qualities, with the capacity to influence and drive change within the organization.
• Outstanding organizational and project management skills, demonstrating the ability to plan, execute, and oversee projects effectively.
• A strong dedication to the principles of continuous improvement, showcasing a commitment to enhancing processes and outcomes continually.
• Participation in continuing education, including engagement with local chapters, associations, and/or organizations related to your field, highlighting a commitment to staying current with industry trends and best practices.

Cretex Companies may use cutting oils, solvents, and other chemicals in the manufacturing process.  Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels.

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.

Company Benefits:

Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay.

Cretex Medical also offers company-specific benefits, such as:

• Employee Appreciation events
• Volunteer Opportunities
• Training and Development opportunities
• Tuition Reimbursement
• New state-of-the-art facility in Brooklyn Park!
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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.