Quality Engineer (1087683)

Location: Deerfield Beach, FL

Salary: $85,000.00 USD Annually - $100,000.00 USD Annually

Description: Job Title: Quality Engineer Location: Deerfield Beach, FL

Our client is a global leader in self-injection device development, design, and manufacturing. With a team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to provide autoinjectors, pen injectors, and drug delivery systems. Headquartered in Switzerland since 2018, with operations in Sweden, Taiwan, and the US, we drive innovation that improves patients' lives while fostering an inclusive and dynamic workplace.

Role

As a Quality Engineer , you will ensure product design effectiveness and compliance with regulations. You will play a critical role in design controls, risk management, and quality processes while collaborating with multiple departments to drive innovation and efficiency.

Responsibilities

• Represent Global Quality Engineering in all Design Controls and Product Development activities.
• Support the application of Design Controls (Quality by Design) in projects.
• Promote Advanced Product Quality Planning and ensure regulatory compliance.
• Facilitate improvements in Product Development and Quality Planning processes.
• Utilize Quality Engineering principles in development and production projects.
• Apply Quality Engineering methodologies to product development based on regulatory needs.
• Support Risk Management for medical devices and combination products.
• Assist SMEs in identifying and tracing Critical-to-Quality (CTQ) factors.
• Review engineering experiments (DOEs) and support data-driven product and process decisions.
• Ensure adherence to SHL procedures and quality standards throughout development and manufacturing.
• Perform other duties as assigned.
  
  

Job Qualifications

Minimum Qualifications:

• Bachelor's degree (or equivalent) in science or engineering.
• 2 years of experience in Quality Engineering or relevant field.
• Knowledge of ISO 13485, QSR, ISO 14971, IEC 62366, and IEC 62304.
• Strong cross-functional collaboration and teamwork skills.
• Solution-oriented growth mindset and strong decision-making ability.
  
  

Preferred Qualifications

• Hands-on experience in Medical Device product development.
• Knowledge of Quality Methodologies (DFSS, DMAIC, Lean).
• Customer-focused with strong stakeholder management skills.
• Effective negotiation and consensus-building abilities.
  
  

Client Offers

• Competitive compensation package.
• Modern working environment with cutting-edge technology.
• Challenging assignments in a growing, innovative industry.
• Collaborative, international team of skilled professionals.
• Career development opportunities in a global organization.
  
  

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