Engineering Program Manager

Type: 5 months

Pay: $45- $55 per hour

Location: Remote

JOB DESCRIPTION

• Prepare Product Bounding input for FCAs identified.
• Provide strategies for Planning, Execution and Closure for FCAs identified.
• Ensure FCA activities are compliant with international regulations (e.g., FDA, EU MDR, ISO 13485).
• Maintain records of field corrective actions, product recalls, and customer notifications in accordance with regulatory requirements.
• Provide guidance and leadership to cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, R&D, Manufacturing, and Customer Service) on FCA-related matters.
• Collaborate with internal stakeholders and external partners to ensure effective resolution and communication of corrective actions.
• Collaborate with Enterprise FCA team to Prepare and submit necessary FCA reports to regulatory agencies, ensuring compliance with FDA and other relevant authorities.
• Collaborate with Enterprise FCA team for timely closure of ongoing FCAs. Provide Remediation support as needed.

TECHNICAL SKILLS

Must Have

• 10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
• Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
• Strong project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
• Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability