POSITION SUMMARY
This position must provide leadership and subject matter expertise in global complaint handling quality system requirements and regulations. This position will manage the following complaint handling processes: complaint initiation, preliminary complaint investigation, call center and investigator staffing / management and complaint handling training. This also includes process monitoring, trending and reporting. This position will work closely with cross-functional groups to ensure proper and timely processing of complaints and other support activities.
The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management. The individual must be comfortable working in a fast-paced and constantly changing environment.
MAIN DUTIES/RESPONSIBILITIES
- Manage the incoming complaint/product report process, the preliminary complaint investigation process and provide expertise global complaint handling requirements for finished medical devices.
- Lead a team of post market call center representatives and specialists (investigators) providing coaching, feedback and development.
- Manage staffing multiple shifts to ensure required coverage is met.
- Perform call handling and investigation activities as needed to support the team.
- Monitor and review incoming calls and documented complaints for completeness, accuracy and compliance.
- Deliver performance reporting on key quality processes and metrics to support compliance monitoring and continuous improvement initiatives.
- Perform, support, mentor, and coach team on medical device QMS requirements and best practices for achieving "best in class" performance and process throughput.
- Ensure that the quality and regulatory compliance is maintained in accordance with both Internal and external quality systems and standards.
- Recruit top candidates for post market surveillance positions and ensure new hires/contractors are properly trained.
- Manage incoming complaint and product reporting process for non-Inspire medical devices, Inspire clinical devices and non-medical software applications.
- Support medical device and vigilance reporting as requested along with returned product and complaint closure teams.
- Manage special projects along with product improvement processes at the direction of quality management.
QUALITY SYSTEM RESPONSIBILITIES
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Ensure all direct reports maintain training records that comply with applicable quality system requirements.
QUALIFICATIONS
Educational Requirements:
Required
- Bachelor's degree in a technical or scientific field or
- Bachelor's degree in any discipline with a minimum of 8 years experience in implantable medical devices
Preferred
- Bachelor's degree in an engineering, nursing or other medical field.
- Master's degree in a technical or scientific field.
Required Experience:
- Minimum 5 - 10 years' experience in the medical device industry.
- Minimum 5 years' experience in managing teams with customer facing responsibilities.
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Extensive knowledge on complaint handing requirements for ISO, FDA and European Medical Device Regulations/QMS Requirements (e.g. ISO 13485; 21 CFR Part 820.198, 820)
- Effective relationship management, ability to network, support and influence across the entire organization.
- Experience supporting external regulatory audits
- Strong interpersonal and communication (both verbal and written) skills.
- Ability to facilitate teams and deliver presentations.
- Strong project and time management skills
- Ability to work on multiple tasks concurrently with changing priorities
- Proficient with of MS Word, Excel, Outlook and PowerPoint
Preferred:
- Experience with Class III active implantable medical devices
- Clinical experience in nursing, sleep or other medical discipline
- Front room experience supporting external regulatory audits
- Advanced computer skills with Excel reporting and SQL
- Internal auditor training or certification
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