This position must provide expertise and leadership in the areas of Quality Management Systems (QMS) information technology, application development, system integration and compliance. This person is responsible for ensuring compliance with global quality system regulations and standards as well as QMS IT system process improvements and integrations with third party software. This position will report to the IT Director with a dotted line relationship to the Quality Systems Director for position responsibilities.
This person will work within Quality Systems and with other functional areas globally to ensure system development, integration and validation activities are completed in accordance with Inspire procedures and geographic regulations. In addition, this role must be flexible for changing priorities, able to work without supervision and have exceptional project management skills.
- Lead project team members through the systems development life cycle, including project definition, requirements gathering, design, development, test, release and delivery for new system implementations.
- Manage specific QMS software projects to assure end user (customer) requirements are fulfilled and QMS processes meet regulatory compliance requirements.
- Develop and maintain technical functional specifications for both new and existing QMS applications as well as supporting applications/integrations
- Lead QMS process automation and system integrations
- Responsible for QMS change management, including operational qualification, performance qualification, configuration management and installation qualification (on prem. only) as well as the supporting documentation.
- Responsible for the development and periodic testing of QMS platform specific technical disaster recovery plans for applications/systems
- Develop, test, implement and maintain system security in accordance with information security policies and alignment with corporate IT initiatives on QMS systems/applications
- Partner with end users to develop process requirements, workflows and system analyses for new QMS projects
Quality Management System
- Develop APIs to facilitate process automation and system integrations
- Develop and improve processes, procedures and tools used in QMS applications
- Develop procedures and work instructions for systems/applications required to meet global regulations
- Support both internal and external regulatory audits by ensuring software validation activities and documentation are defendable.
- Support corrective/preventive actions associated with audit findings or CAPAs
- Lead process performance reporting activities which drive automation for real-time metric reporting using Power BI or similar tools
Bachelor’s degree in Computer Science, Information Technology or equivalent with a minimum of 6-8 of related work experience with IT Quality in life sciences or other regulated industry
Master’s degree in a technical or scientific field
- Experience leading business system implementations
- Minimum of 5 years’ experience testing and documenting software validation activities including IQ, OQ, PQ
- Demonstrated leadership and project management skills with the ability to prioritize and execute.
- Strong project and time management skills, with the ability to work on multiple tasks concurrently with changing priorities
- Knowledge of FDA or other Quality System Requirements. (e.g. 21 CRF Part 820 & ISO 13485)
- Proficient with of MS Word, Excel and PowerPoint
- Proficient with other MS applications (i.e.; Power BI, SharePoint, OneDrive, etc.)
- C+ programming experience
- X++ and in C# programming experience or other .NET Framework languages
- Experience with integrations using MS Dynamic, MS Azure or other applications
- 6-8 years’ experience in an IT role supporting quality or regulatory in the medical device or pharmaceutical industry.
- Demonstrated creative and effective problem solving and original thinking for compliance solutions
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 with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, 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 are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email email@example.com.
Inspire Medical Systems participates in E-Verify.