What are the responsibilities and job description for the CAPA Audit readiness and compliance (Life Sciences & Defense) position at Amaze Systems?
Hello,
Hope you are doing well,
Title: Senior Software Engineer (HDMI, C )
Location: Dallas, TX (5 day onsite)
Job Description:
Skill 1 – CAPA process knowledge (Life Sciences & Defense)
Skill 2 – Strong with Solution designing, Tech Presales, should have executed the project, hands on
Skill 3 – Root cause analysis (5 Whys, Fishbone, FMEA, DMAIC)
Skill 4 – Audit readiness and compliance (FDA, ISO 13485, AS9100, GMP, EU MDR)
Skill 5 – Quality management systems (TrackWise, MasterControl, Agile PLM)
Skill 6- Security and confidentiality compliance (DFARS, ITAR, GDP)
Preference is for resource to be near Pittsburgh, PA
Domain Experience (If any) – LifeScience/ Healthcare
Nice to have Skills: Proficiency in change management & continuous improvement framework
Preference is for resource to be near Pittsburgh, PA but remote is also an option; 10 openings
In this role, you will have the opportunity to support the Corrective and Preventive Action (CAPA) process from issue identification to closure and ensure adequate execution of the process and the quality of CAPA record content. You will be part of our Quality & Regulatory organization. Key Responsibilities: • Project Management: Project manage all CAPA activities from initiation to closure, ensuring timely and effective execution. • Issue Identification and Assessment: Identify and assess issues, ensuring accurate and thorough documentation. • CAPA Data Review: Review CAPA data sources and assist with root cause analysis and quality problem-solving. • Root Cause Analysis: Participate in and/or lead root cause analysis activities to identify the underlying causes of issues. • CAPA Record Quality: Ensure the quality and completeness of CAPA records. • Audit and Review Board Representation: Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings. • Timely CAPA Engineering Tasks: Perform timely, detailed CAPA engineering tasks like assessing issue descriptions and reviewing CAPA data sources. • Process Improvement: Contribute to the continuous improvement of CAPA processes and procedures. • Ensuring Products Meet Standards: Ensuring that our products meet the highest standards.
