The Sr. Quality Management Systems Engineer supports and maintains the quality management systems, processes, and procedures. This role is responsible for improving the QMS to support compliant and efficient business operations.
ESSENTIAL JOB FUNCTIONS*
Own, oversee and maintain the quality management systems, procedures policies, requirement flow downs from applicable standards, regulations and directives as applicable throughout the site.
Assure communication, document control and training for the entire organization. Lead the QMS Training process and execution
Provide compliance accountability for QMS implementation
Lead the development, maintenance, monitoring, analysis, and trending of Quality System metrics
Assist the Director of QA/RA to ensure/follow up/implement corrective actions that are raised by complaints, deviations, internal audit or regulatory inspection
Prepare quality management reviews, and host quality audits
Support document change and design change activities, and represent quality on the change control board. Review and approve documents
Influence policy and procedure content and lead efforts for implementation of Quality Systems improvements
Participate in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality system development
Work with cross-functional teams to identify and eliminate compliance deficiencies and manage the Quality Systems compliance function, and personnel
Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency
Interface with management and partners during inspections, audits, investigations and report-outs as necessary
Ensure compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Ensure that all required training is identified for and completed by all employees
Educate and train engineering/operational/quality/compliance representatives to ensure adoption of QMS best practices
Promote an environment that values and embraces diversity to the benefit of the team
Performs broad variety of tasks in support of quality operations as assigned
Bachelor’s Degree or equivalent in an engineering or technical discipline (or non-technical degree with 4 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements). Master’s Degree or higher preferred
Minimum 2 years Quality Assurance/Quality Engineering experience in the medical device
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Experience in addressing non-compliant situations, such as remediating Warning Letters, Consent Decrees, resolving 483 observations, desired
Demonstrated critical thinking, analytical, collaboration, negotiation & conflict resolution skills. Able to work cross-functionally with various groups
Proficiency with MS Office, MS Project, quality system databases, electronic document management
Organized and detail oriented; proven ability to meet deadlines
Ability to work independently in fast-paced environment with minimum supervision
Dependability: accountable, reliable, responsible, dedicated, committed and fulfilling obligations
InfuTronix is an innovative medical device company delivering industry leading technology for infusion therapy. By combining data collection with portable, intuitive, easy-to-use infusion devices, InfuTronix is committed to helping healthcare providers raise the bar on improved patient outcomes. Headquartered in Natick, MA, InfuTronix specializes in acute regional pain, EMS, PCEA, and PCA home infusion markets.