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, assemblies and finished devices 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 Position Summary
This Quality Engineer will play a critical role in maintaining and enhancing the quality of our molding and medical device assembly processes. You'll work closely with both customers and internal teams to lead quality initiatives, optimize processes, and ensure ISO 13485 compliance. Key responsibilities include conducting risk assessments, resolving customer complaints, supporting validation activities, and implementing advanced measurement methodologies. Your expertise will be crucial in driving continuous improvement, performing root cause analysis, and ensuring our products consistently meet the highest standards.
Responsibilities
Quality Engineer Responsibilities:
Quality Process Development and Control: Lead the development and maintenance of comprehensive process flows, control plans, inspection requirements, PFMEAs, and Master Validation Plans. Focus on optimizing medical device assembly processes and controls, ensuring they consistently yield high-quality products.
Customer Complaint Resolution: Serve as the primary quality liaison with our customers, driving the resolution of complaints through thorough failure analysis, corrective and preventive actions, and trend analysis. Build and maintain strong, quality-focused relationships with our customers.
Measurement Methods and Capability Analysis: Work closely with programming and inspection teams to develop robust, repeatable inspection programs and analysis processes, ensuring our measurement capabilities meet the highest standards.
Medical Device Assembly and Molding: Demonstrate expertise in device assembly and injection molding, focusing on reducing process variation and improving visual and dimensional inspections.
Validation Support: Provide critical support for IQ/OQ/PQ validations of injection molding tools, processes, equipment, and metrology, ensuring compliance and best-in-class performance.
Quality Standards: Establish and evolve robust quality standards and processes to uphold our commitment to delivering top-tier products.
Process Enhancement: Collaborate with cross-functional teams to identify opportunities for process improvement, driving lean initiatives and operational excellence to enhance product quality.
Technical Expertise: Offer technical expertise in quality assurance, ensuring manufacturing processes comply with industry standards and regulations, particularly ISO 13485.
Quality Auditing: Conduct regular quality audits to evaluate compliance with established standards, providing insights and recommendations for improvement.
Data Analysis: Analyze quality data to detect trends and identify potential issues. Use data-driven insights to make informed recommendations for optimization.
Root Cause Analysis: Lead investigations into quality issues using CAPA (Corrective and Preventive Action) methods, identifying root causes and implementing effective solutions.
Quality Metrics: Develop and monitor key performance indicators (KPIs) to track progress toward quality objectives, ensuring consistent achievement.
Leadership: Lead quality initiatives, fostering a culture of excellence within the quality assurance team and across departments.
Supplier Collaboration: Work closely with suppliers to ensure the quality of incoming materials, conduct supplier audits, and maintain strong, collaborative relationships.
Regulatory Compliance: Stay informed of industry regulations and standards, ensuring the organization remains compliant, particularly with ISO 13485 and CFR 820.
Documentation Excellence: Maintain thorough and accurate documentation for all quality assurance processes, audits, and continuous improvement initiatives.
Quality Engineer Requirements:
Bachelor's or Master's degree in an engineering or related field.
At least 3 years of experience in quality engineering
Leadership skills, with the ability to guide and inspire teams.
Proficiency in quality management systems and ERP tools, with the capability to navigate and utilize these systems efficiently.
Exceptional analytical skills, with the ability to identify patterns and trends that are critical for quality improvements.
Excellent communication and interpersonal skills, facilitating seamless collaboration across multifunctional teams.
Comprehensive understanding of industry-specific quality standards and regulatory requirements, particularly ISO 13485 for medical devices.
Adaptability and resilience in a fast-paced manufacturing environment.
Quality Engineer Preferred Requirements:
A strong attention to detail and exceptional organizational skills, ensuring meticulous and systematic work.
Advanced problem-solving and critical thinking abilities, enabling innovative solutions to complex challenges.
Demonstrated leadership qualities, with the ability to influence and drive change within the organization.
Project management skills, with the ability to plan, execute, and oversee projects effectively.
A commitment to continuous improvement, consistently seeking ways to enhance processes and outcomes.
Ongoing engagement in continuing education, including participation in local chapters, associations, and/or industry-related organizations, showing a commitment to staying current with industry trends and best practices.
ASQ Certified Quality Engineer or other relevant certifications are highly valued.
Qualifications
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!
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.
