We are seeking a CAPA & Quality Systems Specialist with 5+ years of experience in a regulated environment to support quality and compliance initiatives. The ideal candidate will lead CAPA projects, ensure adherence to quality systems, and collaborate across multiple departments including Manufacturing, R&D, QA Operations, and Software Development.

Key Responsibilities:

• Lead and manage CAPA projects to ensure timely closure and compliance with quality standards.
• Collaborate with cross-functional teams to maintain compliance with LifeScan software development procedures and industry regulations.
• Review and approve software development lifecycle deliverables.
• Lead Hazard Analysis activities.
• Develop or support the creation of SOPs and Work Instructions.
• Occasionally deliver training sessions on software development procedures.
• Write and execute test protocols and reports as needed.
• Report directly to the Quality Manager and provide regular updates.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5–7 years of experience in CAPA, quality systems, and regulatory environments.
• Strong communication and technical writing skills.
• Prior experience with software development compliance is a plus.