- FDA Regulations
- Six Sigma
- ISO 13485
- Communication Skills
- Six Sigma Certification
Location: Sarasota, FL
This position works collaboratively with quality, manufacturing and engineering to ensure the quality management system is effectively implemented and maintained throughout product realization. The ideal candidate will be someone who has excellent interpersonal communication skills, is hands-on and eager to learn and grow with an innovative, medical device manufacturing company. They are a team player possessing initiative and self-motivation.
Assist with the development and implementation of processes and procedures to ensure that quality standards are achieved.
Assist in the development of quality inspection plans for manufactured and supplied products, processes and components.
Collect metrics data for quarterly performance scorecards.
Evaluate, justify and recommend purchase of inspection equipment.
Provide mentor-ship and direction to QC inspectors.
Analyze, trend and summarize test data to identify quality improvement opportunities.
Prepare quality performance reports and improvement plans.
Preparing validation protocols, validation reports and manage validation projects to comply with process and product validation requirements.
Establish a cross-function team and lead the implement of ISO 14971:2019.
Help manage the investigation and trending of CAPAs.
Manage Material Review Board activities and related documentation to control nonconforming material, direct containment activities, provide timely material disposition, determine root cause and implement corrective actions.
Oversee the calibration program according to calibration schedules.
Assist with environmental monitoring activities in accordance with quality procedures.
Contribute in the design and implementation of quality assurance training programs and conduct quality related training throughout the organization.
Assist with transitioning from a paper based QMS to a software solution.
Education & Experience Requirements:
Minimum 3 years’ quality engineering experience in the medical device industry
Strong working knowledge of FDA QSR, ISO 13485, MDD/MDR
Experience in GD&T and use of advanced inspection equipment
Thorough understanding of statistical analysis and sampling plans
Experience in Minitab and Solidworks or equivalent, required
Knowledge of EO sterilization desirable
Six sigma training a plus
Works in an air-conditioned environment.
Able to sit or stand for extended periods.
Must be willing to wear company supplied, safety and personal protective equipment as required.
Ability to lift up to 20 lbs.
This job description does not list all job duties that may be assigned by management. Management has the right to revise the job description at any time.
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.