Post Market Surveillance Technician

Lead Post Market Surveillance Technician

Onsite: Campbell, CA

8 month assignment Pay Range: $63.00 - $70.00

An individual in this role uses advanced expertise to oversee activities for monitoring the Complaints and Post Market Surveillance System, conducting complaint intake activities, assessing regulatory reporting, leading complaint investigations, submitting regulatory reports, maintaining quality compliance, and achieving quality metrics in areas of responsibility. This position will collaborate directly with customers, Regulatory Agencies, Notified Bodies, and requires extensive knowledge of industry practices, techniques, and standards.

Essential duties and responsibilities include the following:

• Ensure compliance of the Complaints System to internal requirements and applicable Regulations.
• Establish and report on complaint trends with actions for resolution.
• Review adverse event reporting determinations against applicable regulatory requirements (FDA, EU MDD/MDR, PMDA, TGA, etc.).
• Complete reportability assessment and route for approvals in a timely manner.
• Accurately assess risk and escalate high-risk incidents to appropriate management.
• Complete and submit applicable regulatory reporting documents in an accurate and timely manner.
• Determine if an investigation is necessary. Support investigation activities as necessary for complaints processing/closure in a uniform and timely manner. Determine potential cause and contributing factors to the alleged event, device relationship, and whether formal device investigation is necessary.
• Conduct complaint investigations using concise and grammatically correct language appropriate for regulatory review.
• Develop, maintain, and improve procedures for device failure analysis.
• Perform timely, methodical failure analyses of devices, including failure replication to determine cause of device failure.
• Ensure complaints are closed in a timely manner and in compliance with FDA and other regulatory requirements.
• Ensure complaints are prioritized based on patient, product, and compliance risk.
• Communicate with Customers and field reps in a professional manner to gather complaint information.
• Assist with training Customers and field reps to ensure compliance to Post Market Surveillance requirements.
• Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch in the required/applicable geographies.
• Develop and implement complaint event tracking and trending data collection tools.
• Work cross-functionally to compile and generate periodic reports in a timely manner to support Post Market Surveillance activities.
• On an ongoing basis, monitor adequacy of the Complaints, Post Market Surveillance and Recalls System, and identify and implement system improvements.
• Draft new procedures and system changes as needed to accommodate regulatory requirements for new country introductions.
• Ensure the Post Market Surveillance Systems are tied to Risk Management process.
• Support Regulatory submissions by providing Post Market Surveillance data trends.
• Participate in quality system activities and support internal and external audits.
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements.
• Actively promote and support the company's Management Review process.
• Inform responsible personnel of concerns involving product quality.
• Perform job functions in a safe and effective manner.
• Other duties as assigned.

Education/Experience:

• Bachelor's degree in nursing or related discipline and a minimum of 8 years of progressive responsibility in Medical Device Complaint handling of Class II/III devices; or equivalent combination of education and work experience.
• Ability to be self-directed, receive general instructions.
• Experience working with test instruments and tools such as microscopes, measuring equipment, borescopes, etc. as part of device analysis.
• Proficiency in data compilation, analysis, presentation, communication, and document writing skills.
• Working knowledge of cGMP, Medical Device Reporting, FDA 820 QMSR and ISO 13485 or other Quality Systems.
• Proficiency with computer-based applications (MS Word, MS Excel, QAD).
• Strong time management skills and the ability to multi-task in a fast-paced environment.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Effective interpersonal skills to communicate with internal and external customers including physicians, hospital staff, and regulatory agencies

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.