· Key contributor to the Corrective and Preventive Action activities including root cause investigations, verification of effectiveness and trend analysis.

· Work closely with the Customer Complaint handling team to assist in investigations.

· Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action.

· Perform Nonconforming Product activities such as investigation and trend analysis.

· Perform Internal Audits and External Supplier Audits and overall audit support.

· Perform Supplier Management Activities.

· Coordinate U.S. FDA remediation activities.

· Support preparation of Management Review Meeting presentations.

· Attend all department and company-wide team meetings as needed.

· Other duties as assigned.

· Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.

Qualifications

· Bachelor’s degree highly preferred.

· Five (5) or more years of hands-on experience performing Quality System support activities in a U.S. FDA regulated environment.

· Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807).

· Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations).

· Excellent leadership, communication, collaboration, team work and interpersonal skills.

· Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).

· Excellent computer and internet search skills.

· Strong ability to multi-task and to meet business deadlines.

· Excellent organizational skills with an ability to think proactively and prioritize work.

Job Type: Contract

Salary: $35.00 - $38.00 per hour

Schedule:

• 8 hour shift

Experience:

• Regulatory Affairs: 1 year (Preferred)
• FDA regulations: 1 year (Preferred)
• CAPA: 1 year (Required)

Work Location: Remote

Speak with the employer
+91 +14705143640

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