Quality Compliance Specialist
Sekisui Diagnostics
Charlottetown, PE
Scope:
The role of the Quality Compliance group is to ensure that the Sekisui Diagnostics organization continues to adhere to laws, regulations, guidelines and specifications relevant to the diagnostics business. In situations where deficiencies are identified, the group evaluates the level of risk and then implements actions to reduce the risk as much as possible. The Quality Compliance Specialist is responsible for activities focused on quality systems, product safety, post market surveillance, risk management, field corrections, CAPAs and inspection readiness. This position will also provide project management support for quality and regulatory compliance projects and initiatives.

Responsibilities:
May perform some or all of the following:
• Develop and implement quality system improvements to eliminate compliance risks and maximize benefits to the business.
• Responsible to assist in the assessment/confirmation that an adverse event (MDR, Vigilance, MPR) has occurred and then to report to the appropriate agency and/or the authorized representative.
• Lead and/or participate in Customer Satisfaction Review Board (CSRB) activities related to product investigations, MRBs, deviations/NCMRs and SCARs.
• Lead and/or support the post market surveillance process for Sekisui Diagnostics product lines to ensure continued performance on market and to identify and mitigate any issues or risks.
• Lead and/or support the risk management process, product performance analysis and trending to drive risk mitigating reduction activities including health hazard assessments, CAPA, and field actions.
• Assist with Field Actions– this may include developing the field action strategy, presenting for approval, initiation, communication/notification, monitoring/updates, and closure of the action.
• Assess Key Performance Indicators (KPI) for the Sekisui Diagnostics Quality group and prepare reports for the Management Review process
• Support the inspection readiness program and conduct mock audits as assigned.
• Support the corporate auditing function by conducting audits as assigned.
• Provide expertise for CAPA management. Responsible to drive CAPA forward, develop root cause, and monitor actions and effectiveness.
• Support and/or drive LEAN, 5S and Kaizen practices into the quality and regulatory compliance functions.
• Perform activities within the CATSWeb electronic Quality Management System as required.
• Provide quality and compliance expertise to critical business projects (i.e.Directive updates, REACH, UDI, etc.)
• Other duties as required

Education / Experience:
• Bachelor’s degree in health science related field is required.
• Minimum of 6+ years of quality system and quality compliance experience, preferably in a medical device and/or diagnostics manufacturing environment.
• Expert knowledge and experience of quality systems, 21CFR part 820 and the ISO 9000 series standards, ISO 13485, cMDR, JPAL.

Skills / Pre-requisites:
• Willingness to challenge existing systems/practices in order to improve them.
• Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to work effectively with internal and external stakeholders.
• Proficiency with MS Office and software programs for generating reports, presentations and statistics.
• Proficiency with eSystems (CATSweb, ERP, etc.

Training:
• Certified Auditor is preferred.
• CATSWeb training is preferred.
• Green and/or Black Belt Certified, is a plus.
• LEAN Manufacturing, is a plus.