Role and Responsibilities:

• Leadership of ECO Management: Lead a dedicated team in conducting risk assessments, updating pertinent DMR documents, performing essential IQ, OQ, PQ activities if necessary, and finalizing implementation tasks.
• Oversight of DCOs within the PLM System: Develop and revise QA procedures to ensure alignment with quality standards and regulatory mandates.
• Coordination of NCR and CAPA Processes: Guide, draft, and oversee NCR and CAPA processes, ensuring prompt and effective resolutions.
• Supervision of Rework Activities: Author and supervise rework initiatives to uphold product quality and conformity to established standards.
• Support for QA Production Activities: Provide quality assistance to production operations, addressing deviations and non-conformities to sustain superior product quality.
• Timely Resolution of Quality Issues: Swiftly tackle all identified or assigned quality concerns to avert delays and uphold operational efficiency.
• Administration of Arena PLM System: Manage user permissions as an administrator.
• Document Control: Act as a change administrator to maintain meticulous document control.
• Review and Approval of DHRs: Validate and endorse DHRs for batch release, labels, and route cards, while also performing incoming inspections.
• Participation in Audits: Take part in both internal and external audits, including FDA inspections and notified body audits, following ISO 13485, EUMDR, and MDSAP requisites.

Requirements:

• Bachelor’s degree in Science or Engineering.
• 3-5 years of experience in medical device Quality Assurance (ISO 13485, FDA QSR 820).
• Certification as an internal auditor.
• Strong attention to detail and aptitude for self-directed learning.
• Ability to collaborate within cross-functional teams and work independently.
• Exceptional teamwork and a focus on customer service.
• Adaptability and resilience in a dynamic, rapidly growing company environment.
• Competence in time and priority management, and ability to work under pressure.
• Proficiency in English, encompassing reading, writing, and speaking.
• Robust analytical and problem-solving skills, with familiarity in LEAN methodology or equivalent as a plus.
• Proficient in all MS-Office applications, with knowledge of Minitab as an advantage.