Product Complaint Analyst-Medical Device

OLSA Resources, Inc.; Santa Ana (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

A Medical Device Company in Santa Ana seeks a Product Complaint Analyst to analyze product complaints and ensure compliance with quality processes. In this role, you'll coordinate complaint investigations, manage complaint data, and communicate with customers regarding resolutions. Ideal candidates should have a minimum of 2 years in the medical device or pharmaceutical industry and strong computer skills, especially in Excel and complaint management software. This contract position lasts 4+ months with pay based on experience.

Qualifications

• Minimum 2 years in medical device and/or pharmaceutical industry.
• Preferably experience in a complaint handling position.
• Proficient in database management of complaint records.
• Experience with complaints processing software (such as CATSWeb) desirable.

Responsibilities

• Analyze product complaints while adhering to quality processes.
• Perform accurate data entry in corporate complaint database.
• Coordinate complaint investigations as needed.
• Analyzes complaint data to identify trends and informs management for CAPA.
• Works with other departments and vendors to resolve quality problems impacting patient safety.
• Responds to technical or medical information requests from healthcare professionals and consumers.
• Provides ad-hoc reports related to product complaint trending and investigations.
• Plans and prioritizes daily work to meet schedule.
• Manages individual complaints from opening to closing.

Skills

Medical terminology/ophthalmic knowledge

Proficient in Excel and Word

Complaint handling skills

Word

Complaint handling

GMP knowledge

CATSWeb

Tools

CATSWeb

Job description

Product Complaint Analyst - Medical Device (Contract)

Medical Device Company

Responsible for analyzing product complaints while maintaining the quality processes related to post-market product complaints to ensure compliance with all applicable Corporate and Divisional policies and procedures.

Ideal candidate will demonstrate thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO 13485. Actively participates in departmental process improvements and effectively communicates shared knowledge to contribute to overall company success.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Performs accurate and timely data entry in corporate complaint database.
• Coordinates complaint investigations, including determining investigation strategies, as needed with internal and external resources.
• Communicates directly with customers regarding reported complaints and resolutions.
• Analyzes complaint data to identify any trends, and provides information to department management and other personnel that may lead to a Corrective Action Request.
• Works with other departments and vendors on known or emerging issues to resolve quality problems that may impact patient safety.
• Responds to technical or medical information requests from healthcare professionals, personnel and consumers.
• Assists global departments by providing ad-hoc reports related to product complaint trending and investigations.
• Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action. Recognizes that failure to achieve results or erroneous decisions or recommendations may result in significant non-compliance issues.
• Manages individual complaints on various product lines, from opening to closing.

Requirements:

• Minimum 2 years in medical device and / or pharmaceutical industry, preferably in a complaint handling position.
• Medical terminology/ophthalmic knowledge desired.
• Proficient computer skills in Excel and Word, with a good understanding of database management of complaint records.
• Prior experience using complaints processing software (such as CATSWeb) is desirable.

Other Details:

• 4+ month contract
• Pay-DOE

Job Location