Nowhere else can you touch as many life-changing medical technologies. At Minnetronix Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.
The Supplier Quality Engineer will be responsible for activities to promote supplier quality, conducting audits, and implementing quality improvement initiatives to ensure the delivery of high-quality materials from suppliers. This role will involve collaborating with internal teams and suppliers to drive continuous improvement in quality and reliability.
1. Conduct supplier audits to evaluate quality systems, processes, and compliance with quality standards.
2. Develop and implement supplier quality programs to assess and improve supplier performance.
3. Routine maintenance of approved supplier list in accordance with applicable quality standards.
4. Collaborate with suppliers in a timely manner to resolve quality/delivery issues, implement corrective actions, and prevent reoccurrence.
5. Execute supplier change notices (SCN).
6. Monitor and analyze supplier quality performance metrics to drive improvement and ensure compliance with quality requirements.
7. Work closely with cross-functional teams, including engineering, manufacturing, and procurement, to address quality-related issues and ensure product quality.
8. Implement quality control measures and inspection procedures to validate incoming materials and components.
9. Provide guidance and support to suppliers on quality requirements, specifications, and quality management systems.
10. Work in a cross-functional, collaborative, team-based environment
11. Travel approximately 10%
· Bachelor’s degree or 3-5 years equivalent experience
· Demonstrated experience in areas, which may include, process qualification and validation for medical device, materials qualification and validation, problem solving and root cause analysis methods, and risk management methods.
· Proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel.
· Experience in use of statistical analysis software.
· Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.
Preferred Qualifications:
Experience in processes, equipment, and control methodologies for the following commodity industries:
• Printed Circuit Board Assemblies (PCBA) and Printed Circuit Boards
• Stamping and Machining
• Injection Molding
• Displays and Overlays
ERP/MRP systems experience preferred.
Lead Quality Auditor training/certification (ISO 13485 and/or FDA QSR)
· Experience in partnering with Sourcing and Materials professionals
· Demonstrated leadership behaviors including effective communication at various functional levels, critical thinking and decision making, change agent, and embodying a strong sense of urgency.
We work hard and work together towards a common goal.
We put aside narrow interests to pursue the best outcomes for the company.
We aspire to collective excellence and know the sum is greater than the parts.
We own our successes and our failures and believe in growth through self-improvement.
We listen, learn and know when to make tough decisions.
We step up and step in, always.
We move out of our comfort zone in order to do what’s right and not just what’s easy.
We lead change effectively, operate with integrity and hold ourselves accountable.
We are driven to improve life for patients.
We relentlessly create and deliver value for our customers.
We constantly challenge ourselves to improve our thinking and our doing.
Minnetronix, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.