Quality Management Systems (QMS) & Complaints Manager

 

Position Title: QMS & Complaints Manager

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: 

 

 

Summary

 

Quality Systems Managers monitor production processes to ensuring 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 guidance for this area of QMS and Complaints Management for the company overall 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. Monitors the training and growth of people reporting to him or her. Formally reports activities and outcomes to his manager on a frequent basis.

 

 

Essential Duties and Responsibilities:

  • Support the implementation and management of new electronic PLM and QMS 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), Document Change Requests (DCRs), Change Controls (CCs), version controls/release of updated component and device drawings, and Bill of Materials (BOMs).

  • Support device complaint investigation and failure analysis as required.

  • Provide in-process QA support and management for implementation of a customized Quality Management System (QMS), including a Complaints Management process.

  • Support the implementation of incoming documentation into the QMS, vetted for Quality and compliance.

  • As required, act as QA representative in pertinent supplier/vendor interactions.

  • Support cross-functional design meetings and activities as core team QMS Quality representative.

  • Assist in the drafting and reviewing new compliance policies, processes, and procedures.

  •  Monitor and report on relevant KPIs and metrics to assess and correct the health of the process.

 

Education:

  • 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.

 

Experience

 

A career trajectory indicative of roles of increasing experience and responsibility, with 6+ 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.

  • Management experience demonstrated with direct reports and contract staff.

  • Supplier management experience.

  • Experience within 1 or more QMS systems for 4+ 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 Controls.

 

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones

 

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

 

Travel

  • Some travel may be expected for this position including internal meetings, conference and or training events

 

EEO Statement

  • Lumicell is an equal opportunity employer

 

Other Duties

  • 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 careers@lumicell.com.