Sr. Quality Assurance Analyst; regulatory/Medical Device

Company: Change Healthcare
Location: Richmond
Posted on: January 12, 2021

Job Description:

Transforming the future of healthcare isn---t something we take lightly. It takes teams of the best and the brightest, working together to make an impact.As one of the largest healthcare technology companies in the U.S., we are a catalyst to accelerate the journey toward improved lives and healthier communities.Here at Change Healthcare, we---re using our influence to drive positive changes across the industry, and we want motivated and passionate people like you to help us continue to bring new and innovative ideas to life.If you---re ready to embrace your passion and do what you love with a company that---s committed to supporting your future, then you belong at Change Healthcare.Pursue purpose. Champion innovation. Earn trust. Be agile. Include all. Empower Your Future. Make a Difference.Overview of PositionResponsible for planning and executing quality assurance programs, including audit programs, supplier management program, corrective and preventive actions, and quality metrics. Supports ongoing improvement initiatives and drives changes to quality system processes. Supports mission and objectives for Change Healthcare Canada Company QARA by creating and promoting a quality culture, and provides advice and counsel to company staff, as needed.What will be my duties and responsibilities in this job?Provides subject matter expertise on the interpretation of applicable medical device regulations and standards as they apply to IWCS products, and processes; plans and performs audit-related activities, including planning, conducting and reporting on internal and supplier audits and following up on audit findings.Leads the organization in the preparation for and conduct of external audits performed by third parties; actively participates in and leads quality improvement initiatives or other quality system changes, when required; establishes and maintains Standard Operating Procedures, as required.Reviews and approves quality records; completes and follows up on assigned Corrective Action/ Preventive Actions (CAPA) and Quality System Change Control activities; provides input to supplier qualification and evaluation activities.Trains, advises, coaches, and otherwise educates staff to ensure adherence to all applicable quality standards and procedures for assigned areas; participates (or leads) in the compilation, analysis, follow-up, and reporting of QMS-related metrics.Administrates aspects of an automated Quality Management System enterprise solution as required; collaborates with Quality Assurance and Regulatory Affairs and business unit personnel, as required.What are the requirements needed for this position?5 years of quality systems experience within the medical device industry preferred. Will consider pharmaceutical or life sciences industry background.Working knowledge of medical device regulations in Canada, the United States and the European Union strongly preferred.Experience in the software development industry preferred.Bachelor---s degree in a related discipline; or Diploma in Quality Management, Regulatory Affairs, or Operations Management, or other related training or work experience.What other skills/experience would be helpful to have?Ability to prioritize, multi-task and perform in a complex environment.Independent, proactive, collaborative and self-motivated and a team player.Able to interact constructively with other departments, internal and external customers.Strong verbal and written communication skills.Strong problem solving/decision-making capabilities.What are the working conditions and physical requirements of this job? General office demandsJoin our team today where we are creating a better coordinated, increasingly collaborative, and more efficient healthcare system Full time

Keywords: Change Healthcare, Richmond , Sr. Quality Assurance Analyst; regulatory/Medical Device, Professions , Richmond, California