Responsible for day-to-day support of various aspects of the Quality Management System, including document control, receiving inspection, non-conforming materials program, calibration program, batch record/device history records reviews, training records, quality record management, etc., providing an opportunity to apply textbook knowledge with practical experience. This position requires flexibility, initiative, ability to work well with others and willingness to take on new responsibilities.
- Serves as QA interface and support for quality systems questions.
- Leads and/or Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
- Reviews and assesses the appropriateness of document changes in accordance with internal procedure.
- Reviews and assesses change control, validation, and qualification documents, for impact to quality systems.
- Leads and/or supports department meetings by preparing appropriate Agendas and meeting minutes with minimal supervision.
- Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.
- Performing document uploads into our electronic document control system.
- Maintaining the company’s quality system documentation.
- Providing quality system training to new hires.
- Performs duties in support of established records management procedures, including scanning, filing. Participate in internal audits.
- Ensures proper maintenance of document master copies and original production records.
- Work with internal teams to resolve discrepancies and compile required changes to documents.
- Work with document authors and reviewers to process document changes within project timelines and in accordance with established procedures.
- Coordinates document changes within a document management system.
- Assist in updating procedures and work instructions.
EDUCATION & EXPERIENCE:
- Bachelor’s degree preferred.
- Minimum 3 – 5 years of experience working in a quality or regulatory role.
- Must have a working knowledge of FDA Quality System Regulation, ISO Standards and other regulatory agencies.
- Exceptional organizational skills.
- Work independently and be able to prioritize numerous duties.
- Excellent written and verbal communication skills.
- Ability to work effectively in a positive, fast-paced, start-up, team environment.
- Expertise with MS Word, Excel, Office software.
- Effective communication (both oral and written) required for interacting with all departments within the company.
HIGHLY DESIRABLE SKILLS:
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Excellent communications and presentation skills.
- Ability to lead, influence, create and work within cross-functional team environments.
- Assertive, take-charge, positive “can do” attitude and a sense of urgency to get things done.
- Dedication to quality.
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee might occasionally lift and/or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- General office environment.
- Daily exposure to PCs and networks.
- The noise level in the work environment is usually moderate.
- Travel might be required.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
The physical demands and work environment characteristics described above represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
If you are interested in applying for employment with IRRAS please apply here