Quality Engineer

Company: SunMed
Location: Grand Rapids
Posted on: May 26, 2023

Job Description:

COMPANY DESCRIPTION

SunMed is a respected North American manufacturer and distributor of one of the most comprehensive portfolios of consumable medical devices for anesthesia and respiratory care. For more than 40 years, SunMed has expanded their product offering by adding reputable brands such as Salter Labs, Ventlab, Ethox Medical, and Westmed. The SunMed family of brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind.

POSITION SUMMARY

This position is focused on product quality and supports Production, Incoming Inspection, Purchasing, Customers, Suppliers and Engineering. This function interprets, defines, and develops product quality requirements, as needed. It is also responsible for identifying, analyzing, troubleshooting, and resolving non-conformance issues. In addition, this position will drive continuous improvement in quality processes.

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

• Understanding and experience in AQL inspection, control plans and interpretation of spec and drawings.
• Basic understanding of mechanical engineering concepts.
• Ability to analyze defective products.
• Strong decision-making abilities.
• Demonstrated technical writing skills.
• Proven ability to work across organizational functions.
• Strong ability to multi-task and to manage time. Level of Experience:
  • 3+ years of experience in Quality is highly preferred.
  • Exposure to the FDA, medical device or medical manufacturing is a plus.
  • Experience in continuous improvement is preferred.
  • Experience in supplier management and development is a strong plus.
  • Experience in quality systems and management is a strong plus. Level of Education:
    • A bachelor's degree in mechanical, biomedical, industrial, or manufacturing engineering is preferred.
    • ASQ certification is preferred. Travel:
      
      approximately 15% including international travel. Travel to China and Mexico is expected.
      
      ESSENTIAL DUTIES AND RESPONSIBLITIES
      
      The core tasks, duties, and responsibilities that must be performed on the job.
      • Support day-to-day manufacturing quality and production processes.
      • Investigate and respond to manufacturing nonconformances.
      • Investigate and resolve internal product non-conformances.
      • Initiate and manage Corrective Actions and Preventative Actions (CAPAs)
      • Support validation activities for new tooling, manufacturing transfers, and new product introductions.
      • Manage MRB material.
      • Interpret spec and requirements for Production and Incoming Inspection.
      • Initiate continuous improvement projects for product quality through the use of data analytics.
      • Collaborate with Sustainment Engineering, New Product Development, Sales, and Marketing on new opportunities and product improvements.
      • Support the management of the Quality System with process improvements.
      • Represent SunMed's quality system in internal and external audits, as per ISO 13485. OTHER RESPONSIBLITIES
        • Focus on achieving our Company mission.
        • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
        • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
        • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
        • Contribute to building and maintaining a positive team environment.
        • Assure all policies and guidelines are implemented and followed.
          QUALITY POLICY
          
          At SunMed, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.
          
          DEIA STATEMENT
          
          At SunMed, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.

Keywords: SunMed, Grand Rapids , Quality Engineer, Engineering , Grand Rapids, Michigan