What are the responsibilities and job description for the CAPA Coach position at Hired by Matrix, Inc?
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a CAPA Coach.
Position Type:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at (201) 478-6913 to learn more.
#HbM6349
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a CAPA Coach.
Position Type:
- Contract
- Remote
- Bachelor’s degree in a technical or scientific discipline (or equivalent experience in regulated quality systems).
- 8 years of experience in Quality Management Systems, preferably within the medical device industry.
- Deep expertise in CAPA processes, root cause analysis, and regulatory compliance.
- Strong knowledge of FDA 21 CFR 820, ISO 13485, and other relevant global quality regulations.
- Proven ability to coach, mentor, and lead cross-functional teams in CAPA execution and QMS remediation.
- Excellent analytical, communication, and technical writing skills, with experience presenting to executive leadership.
- Demonstrated experience in managing multi-threaded remediation efforts, supporting audits, inspections, and continuous improvement initiatives.
- Serve as the Subject Matter Expert (SME) for CAPA processes, providing guidance on root cause analysis, risk assessment, corrective actions, and best practices.
- Lead and execute CAPA Coaching activities within the CAPA Workstream, mentoring owners and cross-functional teams on proper CAPA breadth, depth, and execution.
- Support interim controls and risk mitigation during remediation investigations, ensuring measures are effective and documented until permanent corrective actions are implemented.
- Assist in remediation and redesign of CAPA procedures, tools, templates, and records to address gaps, audit findings, or regulatory observations.
- Monitor and evaluate CAPA effectiveness, providing metrics, dashboards, and insights to drive continuous improvement.
- Deliver training and mentorship to junior staff and cross-functional teams, enhancing adherence to CAPA processes and technical skills.
- Collaborate across functions, serving as a point of escalation for complex or systemic CAPA issues, and support QMS remediation initiatives across multiple sites.
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at (201) 478-6913 to learn more.
#HbM6349
Salary : $56