Quality Specialist

Location: Sarasota, FL

Summary of Primary Responsibilities:

This position is responsible for performing various QA activities in assigned areas per the quality management system and requires a working knowledge of ISO 13485:2016, FDA QSR and EU MDR.  Prior experience with eQMS and Sharepoint highly desirable.

Specific Responsibilities:

  • Contributes to development, review and revision of procedures in accordance with the QMS.
  • Involved with administration and maintenance of the company’s eQMS and Sharepoint sites.
  • Assists with the final review and release of batch record documentation and preparation of Certificates of Analysis.
  • Oversees the change control process and monitoring timely closure of change orders.
  • Facilitates reviews of CAPA, NC and Deviation processes and monitors inputs to ensure timely completion.
  • Assures quality trends and respective observations are documented and escalated in accordance with company procedures.
  • Prepares KPI reports as an input to Management Reviews.
  • Performs activities related to personnel training and maintenance of training documentation in MasterControl.
  • Performs periodic review of controlled documentation and assessments of internal files and manages the off-site storage of controlled documents.
  • Monitors the approved supplier list and assists with supplier evaluations.
  • Participates in QA-related meetings:  scheduling, agenda, minutes and action item management.
  • Participates in audits and inspections by assisting with audit scheduling, preparation and set-up, providing documentation, and other audit and post-audit activities as needed.

Job Complexity:

Job requirements are diverse in scope which require the ability to maintain quality work while prioritizing and managing multiple deadlines.  Excellent attention to detail and organizational skills are necessary for success.  Requires a working knowledge of FDA, ISO, and other regulatory requirements related to the manufacturing of medical devices.

Supervisor Responsibilities:

No direct reports. 

Experience, Knowledge and Skills Required:

  • Bachelor’s degree in a life science or related discipline.
  • 5 – 7 years of medical device quality system management experience or an acceptable combination of education and experience will be considered.  Internship experience may be considered.
  • Strong technical skills and understanding of software systems; eQMS and Sharepoint experience highly desirable.
  • Working knowledge of requirements related to ISO 13485:2016, FDA QSR and EU MDR
  • Excellent written and oral communication, attention to detail, organizational and planning skills.
  • Ability to work with different departmental designees on quality-related activities.
  • Team player with the ability to multitask and prioritize projects
  • Knowledge of statistical process control methods and techniques a plus.

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.