Cardinal Health Principal Specialist, Quality Systems (Post Market Compliance) in Mansfield, Massachusetts
What Quality System Management contributes to Cardinal Health
Quality Systems Management is responsible for the development, deployment and maintenance of controlled documentation and supporting systems.
The Post Market Compliance Specialist will report into the Quality Manager of Post Market Compliance; responsible for collaborating with multi-disciplinary teams to develop Health Hazard Analysis (HHA) / Issue Impact Assessment (IIA) documentation for the Patient Monitoring and Recovery (PMR). This position is expected to lead and support key post market quality efforts for product related issues within the PMR Business. They will coordinate the investigation of post market assessments, ensure alignment with functional groups, carry out product notifications related to field actions, and deployment of corrective and preventive actions.
This role is focused on maintaining and improving process and product performance and monitoring.
- Collaborate with multi-disciplinary teams to develop Health Hazard Analysis (HHA) / Issue Impact Assessment (IIA) documentation across the PMR product portfolio.
- Exposure to or experience working in or with Design, Quality, Development Engineering, Clinical Affairs, and Manufacturing
- Assess data, statistical results and datasets and assure that documents explain data in non-technical language
- Monitor HHA completion from initiation through approval.
- Maintain HHA / IIA metrics.
- Review and support clinical analysis and provide input on clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA’s, Risk Management Report and develop and maintain clinical risk-benefit document in support of new product development and regulatory requirements.
- Respond to requests for data related to IIA metrics.
- Participates on teams related to special projects/programs.
- Support PMR Business process improvement projects, as required.
- Working knowledge of field action and recall processes, including initial notification and follow up communication with FDA.
- Collaborate with internal function to develop appropriate responses to requests for additional information from various regulatory bodies.
- Work with minimal supervision
- Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements
- Bachelors in related field, or equivalent work experience, preferred
- 4+ years’ experience in related field, preferred
- Some traveling may be required to provide support to other locations of the corporation
- Proficiency in Word, PowerPoint, Excel
- Demonstrated ability to communicate clearly both verbally and in writing to both technical and non-technical audiences both internal and external to Patient Monitoring and Recovery business.
- Must be a team player – willing to work with other departments and divisions across locations
- Excellent documentation skills.
- Attention to detail, highly organized and a commitment to quality work
- Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR 820, 806, 803, 804, ISO13485, and MDD)
- Working knowledge of product risk management standards and tools (ISO14971, IEC 60601, pFMEA, dFMEA, etc.
- At least 3 years’ experience working in vigilance/safety area concerning Class I and Class II Devices and/or pharmaceutical industry or in related fields such as clinical research, or medical affairs
- Experience in clinical research or Medical Safety monitoring.
- Experience with application of Risk Management to Medical devices. Excellent critical and analytical thinking skills.
- Knowledge of ISO standards and FDA regulations related to Quality Systems, Medical Devices, and Risk Management.
- Proven analytical skills working with Medical Safety data.
- Proven communication skills, including written and oral presentation of scientific data and research results.
- Effective scientific writing skills.
- Proficient computer skills with experience in Microsoft Office Word, PowerPoint, and Excel. Knowledge of basic statistical techniques
- Project management experience
- Compliance fluency as per QSR, GMP, ISO Regulations
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.