The Quality Assurance Engineer reports to the VP, Healthcare Technology Management and Quality Assurance and will have primary responsibility to ensure that processes needed for the Quality Management System (QMS) are established, implemented, and maintained in accordance with ISO 9001:2015 quality standards. This includes but is not limited to; preparing/maintaining necessary documentation, monitor quality performance to identify opportunities for improvement, review and maintenance of quality management system procedures and adherence to RENOVO Quality System. Provides oversight for quality management system and should work with Clinical Engineering & QA department to develop policies and procedures that comply with the ISO 9001 requirements.
Essential Duties & Responsibilities:
- Ensure that processes needed for the Quality System are established, implemented, and maintained.
- Ensure that a document control procedure is adopted to approve, review, and update all changes to critical documents within the scope of the QMS.
- Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed.
- Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training, as necessary.
- Ensure that all suppliers used by the organization are selected, evaluated, and reevaluated and that records of this assessment are maintained.
- Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements and is effectively implemented and maintained.
- Responsible to draft, edit, revise, and update as necessary all documents associated with the Quality Manual and Quality Management System.
- Responsible to write internal Corrective Action Reports. Responsible for customer, supplier and internal corrective and preventive action initiation, follow-up, and closure.
- Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
- Keep Management fully apprised of significant occurrences and trends that impact the quality of service or operations.
- Anticipates current and future issues and develops plans and actions to minimize the negative impact.
- Liaise with the external assessment body on all matters related to the accreditation process.
- Performs other duties as assigned**
- Associates degree or bachelor’s degree in Business or related field is preferred
- Minimum 3 years as a Quality Engineer is required
- Trained ISO 9001:2015 Internal Auditor is required.
- Demonstrated background in an ISO 9001 or ISO 13485 quality and regulatory system.
- Medical device industry experience is preferred.
- ISO9001:2015 lead auditor certification is preferred.
- Ability to multitask and deliver expected results
- Strong computer skills (Excel, Word, Power Point)
- Demonstrate responsibility, respect, dependability, patience, and productivity in order to create a positive work environment
- Strong verbal and written communication skills
- Strong organizational skills and motivational skills.
- Ability to work independently, as well as within a team.
- Thrives in a collaboration culture. Must be able to work with teams, and to facilitate effective meetings.
Must be willing to travel including airline travel and overnight stays.
RENOVO Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, RENOVO Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
RENOVO Solutions expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of RENOVO’s employees to perform their job duties may result in discipline up to and including discharge.