Sartorius-posted 3 months ago
San Francisco, CA
5,001-10,000 employees

We are seeking a Software Support & Development Engineer to deliver high-quality technical support and build innovative software solutions for the pharmaceutical and biotech industry. This role combines customer engagement and problem resolution with end-to-end software development, including requirement gathering, prototyping, design, coding, testing, documentation, and deployment. The ideal candidate will ensure compliance with quality standards, collaborate closely with product management and cross-functional teams, and drive continuous improvement to enhance both product performance and customer experience.

  • Provide technical support to customers regarding quality-related issues in collaboration with the support team.
  • Address inquiries, complaints, and feedback promptly and professionally.
  • Investigate and resolve quality issues reported by customers or identified during inspections.
  • Conduct root cause analysis and implement corrective actions to prevent recurrence.
  • Maintain detailed records of quality issues, investigations, and resolutions.
  • Prepare reports and documentation for internal and external stakeholders.
  • Work closely with cross-functional teams, including Production, Engineering, Service, Support, Sales, Product Management, Product Development, and Customer Service, to address quality concerns and improve product quality.
  • Identify opportunities for process improvements and implement changes to enhance product quality and customer satisfaction.
  • Provide training and support to customers and internal teams on quality standards, complaint management, and procedures.
  • Gather and analyze customer feedback to identify trends and areas for improvement in product quality and service delivery.
  • Prepare and present quality reports to management, highlighting key issues, resolutions, and improvement strategies.
  • Engage directly with customers to clarify queries, align requirements, and ensure timely resolution of issues.
  • Bachelor’s degree in Computer Science, Information Technology, Engineering, or related technical discipline.
  • Minimum 3–5 years in software support, complaint management, or quality-related roles, preferably in a regulated industry.
  • Hands-on experience with Azure DevOps (or similar tools) for issue tracking and reporting.
  • Strong background in software complaint management processes.
  • Proficiency in root cause analysis, conflict analysis, and CAPA implementation.
  • Basic knowledge of SQL, scripting, or programming for troubleshooting and data analysis.
  • Familiarity with GMP, 21 CFR Part 11, and ISO quality standards (awareness level sufficient).
  • Exposure to pharmaceutical or life sciences regulatory environments is a plus.
  • Strong experience in managing customer queries, complaints, and escalations.
  • Proven ability to coordinate effectively with internal teams to align on solutions.
  • Excellent communication and presentation skills, both written and verbal.
  • Analytical and detail-oriented with a problem-solving mindset.
  • Adaptable and proactive in managing multiple priorities.
  • Customer-first approach with strong interpersonal skills.
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