Your role with the company:

• Team Collaboration and Customer Interaction: 
  • Work cooperatively with all employees in a team environment.
  • Serve as the quality representative on cross-functional new product development and production teams.
  • Respond promptly and professionally to internal and external customer requests pertaining to quality.

• Regulatory Compliance and Quality Systems: 

  • Initiate and maintain regulatory requirements for FDA, ISO, and other applicable standards.   
  • Develop and maintain Validation/Qualification Protocols to meet regulatory and customer requirements.
  • Perform internal audits based on established schedules and regulatory standards.

• Product Quality and Improvement: 

  • Develop inspection procedures, standards, and equipment to maintain product quality.
  • Work closely with the metrology team on product inspections, capability studies, and gauge R&R.
  • Review data for accuracy prior to customer submission.

• Root Cause Analysis and CAPA: 

  • Utilize robust Root Cause Analysis (RCA) skills to investigate and determine the root cause of product quality issues and defects.
  • Implement effective solutions to resolve quality issues identified through RCA.
  • Assist production and other personnel with the Corrective Action process.

• Continuous Improvement: 

  • Identify and implement continuous improvement opportunities to streamline production and quality systems.
  • Establish and execute quality priorities aligned with company goals and customer expectations.

• Team Mentorship: 

  • Provide mentorship and guidance to team members to enhance quality skills and capabilities.

Desired Profile:

• Bachelor’s degree in engineering or equivalent experience.
• Valid identification and the ability to work legally in the United States.
• 3-5 years’ experience in quality, preferably in a manufacturing environment.
• Strong knowledge of FDA regulations, ISO standards, (particularly ISO 13485), CFR 820, and AS9100.
• Excellent interpersonal and communication skills.
• Proficiency in Microsoft Office, Minitab, and ERP systems (e.g., Epicore).
• Strong data analysis skills and understanding of statistical process control (SPC)
• Demonstrated ability to lead large, complex programs and mentor team members.
• To be able to perform daily tasks safely; to work independently with limited supervision; To be able to effectively apply problem solving techniques and work with customers, vendors and other departments; to manage multiple priorities.