Manager, Post Market Surveillance

Inspire Medical Systems, Inc.; Minneapolis (MN); Hybrid; USD 106,000 - 145,000; Full time

Benefits offered by this job

401k matching

ESPP

Flexible time off

Tuition reimbursement

Job summary

Inspire Medical Systems, Inc. seeks a senior Quality/Complaint Handling Leader to oversee global complaint handling quality system requirements and regulations for finished medical devices.

The role manages initiation, investigation, call center staffing and training, with cross-functional collaboration for timely processing. You will build a high-performing team, drive metrics-driven reporting, and mentor staff on ISO 13485 and FDA QMS requirements while upholding patient safety and regulatory

Qualifications

• Bachelor’s degree in a technical or scientific field is required.
• Minimum 5–10 years’ experience in the medical device industry with leadership in customer-facing roles.
• Experience with ISO, FDA and European Medical Device Regulations/QMS.
• Strong communication and ability to manage cross-functional teams.

Responsibilities

• Manage the incoming complaint/product report process and preliminary investigations.
• Lead a team of post-market call center representatives and investigators.
• Staff shifts to ensure coverage and coach on best practices.
• Provide performance reporting on quality processes and metrics.

Skills

Complaint handling

Leadership

Regulatory knowledge

Quality systems

Project management

Education

Bachelor’s degree in technical or scientific field

Bachelor’s degree with 8+ years in implantable medical devices

Tools

MS Word

Excel

Outlook

PowerPoint

Job description

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!

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

#LI-Onsite

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.

$106,000 - $145,000 USD

BENEFITS AND OTHER COMPENSATION

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com

Inspire Medical Systems participates in E-Verify.