Position Title: Sr. Specialist, Engineer, or Manager – Quality Management System (QMS)
Position Type: Full Time
Job Type: Experienced
Reporting To/Department: Quality Manager
QMS Managers create and monitor quality processes to ensure that equipment, instruments, and people produce products and services in accordance with company and industry regulatory requirements. The role, within an innovative combination medical device company, provides clear quality guidance by ensuring clear policies, procedures, instructions, forms, and objectives are provided. The selected individual coordinates strategies and objectives with other functional leaders so that high level objectives are met.
The responsibilities of the Quality Management Systems & Complaints Manager role at Lumicell include, but are not limited to, the following duties:
- Author the majority of quality processes for the company including training, document control, complaints management, statistical techniques, inventory management, distribution and other logistics-focused processes.
- Serve as the document / change control SME for the company and manage the completion of Change Requests for the cross-functional team including RD, Medical Affairs, Marketing and Finance.
- Support the implementation, configuration, and management of new electronic PLM, QMS, and ERP software including document organization and migration.
- Support daily operations of internal quality system including the full document lifecycle for Nonconformity Reports (NCRs), Corrective Actions/Preventative Actions (CAPA), version controls/release of updated component and device drawings, and Bill of Materials (BOMs).
- Monitor the completion and documentation of training across the different functions of the company. Develop a complaints management process and work with product quality to track device complaint investigations and failure analysis as required.
- Develop a robust approach for statistical techniques to determine sample sizes for different types of products / testing
- Support cross-functional meetings and activities as core team QMS Quality representative, as necessary.
- Monitor and report on relevant KPIs and metrics to assess the effectiveness of the QMS.
Minimum of a bachelor’s degree in a life sciences, healthcare, or technology discipline. Industry certifications, Master’s degree, or higher given preference, depending on experience.
A career trajectory indicative of roles of increasing experience and responsibility, with 5+ years in a pharma and/or medical device company. Ideally, one or more prior role(s) would include a clinical-stage company with ongoing clinical trials management.
Experience within 1 or more QMS systems for 3+ years, Arena preferred.
Experience managing and/or working within a Complaints Management system, per ISO 13485:2016 and 21 CFR 820.198.
Experience investigating, writing, and reviewing deviation and nonconformance reports, CAPA, and Change Requests.
- This position does not currently have supervisory responsibilities over other managers.
- This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers, and smartphones.
- Lumicell has an implemented and strictly enforced COVID Policy that’s intended to keep all employees safe when working on-site. Our policy mandates: restricted number of employees on-site at a time, a socially distanced and protected seating structure, mandatory mask-wearing, and daily cleaning & disinfection of all communal areas.
- Employees are given full flexibility to be able to work on-site and remotely in order to help limit the amount of person-to-person exposure. On-site vs. remote working percentages will depend on the individual’s responsibilities and project needs.
- Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.
Position Type/Expected Hours of Work
- This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
- Some travel may be expected for this position including internal meetings, conference and or training events.
- Lumicell is an equal opportunity employer
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
To apply for this position, please send your resume to email@example.com.