Department: Quality and Regulatory
Work type: Full Time – Permanent
FLSA Classification: Exempt
Hours: 9am – 6pm but can vary
Reports to: CEO
Location: Nottingham, MD
Summary of Role
Oversee the regulation process for products requiring governmental approval. Coordinates inspection of the organization and contract facilities.
Maintain and continuously improve the quality management system (QMS) and perform other quality assurance tasks to maintain the company’s compliance to FDA, Europe, Canada, Australia Medical Device Regulation, ISO 13485 and all other currently approved countries. Work closely with all staff to ensure that all aspects of the QMS are understood, implemented and maintained. Be the champion for quality in the company. Other quality positions may report to this person. Act as the QMS management representative.
Essential Job Functions
Quality System Management
- Be the QMS management Representative
- Chair the Management Review meetings
- Maintain the Quality Management System to all approved countries and applicable standards including: FDA, EU, Canada, and Australia regulations and ISO 13485
- Lead and host all applicable audits by outside bodies.
- Assure that the corrective and preventative action program is effective
- Provide Quality Planning for products, verifications and validations
- Develop metrics to measure quality of products and efficiency of the QMS
- Manage and maintain complaint system
- Assist in supplier qualifications, maintain the supplier files, assure supplier reevaluations, and perform vendor audits, where necessary
- Provide QA system training
Manage the calibration process including manage equipment and maintenance
- Ensure that all test equipment requiring calibration remains in calibration
- Ensure that equipment out for calibration does not interrupt regular operations
- Ensure that work is conducted as per RTI procedures including QOP-63-01
- Monitor/Audit Design Control Process
- Assure proper maintenance of Quality Records
- Monitor the regulatory environment for changing Quality policies, processes and procedures
- Manage a number of key quality system processes as listed in Quickbase and Greenlight Guru
Staff Management
- Ensure that all operations staff are trained to perform the work being conducted
Essential Incumbent Requirements: Minimum
- Bachelor’s Degree in Engineering or Science field or equivalent
- Exceptional communication skills
- Superior time management skills
- Knowledge of ISO 13485 and FDA, EU, Canada, Australia, and other medical device regulations
- Knowledge of basic statistical methods and sampling techniques
- An ASQ or RAPS certification is highly desirable
- Able to travel occasionally including over weekends if needed
Limitations and Disclaimer
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.
Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
Continued employment remains on an “at-will” basis. This job description in no way creates an implied contract.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
