The Operations Quality Engineer will be responsible for Quality System elements including: supplier management, corrective and preventive action, change control, customer complaints, deviations, non-conformities, device history record review and lot releases.
- Manage and perform quality system supplier audits as required.
- Author, review and approve SOPs, protocols, test reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and IRRAS internal procedures.
- Maintain IRRAS Quality Activities-deviations, non-conformances, CAPAs, customer complaints, process change controls, recalls, etc.
- Coordinate and lead investigations for corrective and preventive action (CAPA).
- Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality.
- Review, consult, and approve (as authorized) risk analysis performed for ECOs, NCMRs, recalls, etc.
- Manage process engineering change orders and maintain controlled documents. Investigate and works with other departments to resolve quality issues related to area assigned.
- Work with R&D and manufacturing on the development and incorporation of Risk Management and compliance to standards during all design phases for new and/or product enhancements.
- Participate in internal and external compliance audits.
- Provide day-to-day guidance and training to other QA personnel, as required.
- Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products.
- Performs trending of established quality metrics.
- Plan and schedule projects in a manner consistent with corporate objectives.
- Work with product development staff to ensure that products under development are compliant with FDA and ISO requirements.
- May perform additional duties as assigned or directed by management from time to time.
- Bachelor’s degree in life science or related field or the equivalent combination of education and/or experience. Engineering degree preferred.
- 5+ years’ quality experience in biotech or Medical Device/IVD industries (GMP regulated environment) working in a Quality Assurance role
- Knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
- 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.
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.
- Demonstrates the ability to take initiative and manage change.
- Highly detailed orientated with a critical degree of accuracy regarding data entry and analysis.
- Ability to collect and analyze information, problem-solve, and make decisions.
- 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.
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