At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.
The Quality Compliance Specialist is responsible for post market activities to support IVD placed on market to ensure compliance with FDA regulations, GMP/QSR, ISO 13485, global regulatory bodies, and other applicable quality system regulatory standards. Responsibilities include maintenance of risk management files, design history files, and post market surveillance files. Performs risk analysis where compliance deficiencies are identified, evaluates the risk, and assists in implementation of actions to reduce risk. May provide project support for quality and regulatory compliance projects and initiatives.
Will perform some or all of the following:
• Develop and implement quality system improvements to eliminate compliance risks and maximize benefits to the business
• Assist in the assessment/confirmation 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, Corrective and Preventative Action (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
• 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
• Provide quality and compliance expertise to critical business projects (i.e. Directive updates, REACH, UDI, etc.) Support the inspection readiness program and conduct mock audits, as assigned
• Support the corporate auditing function by conducting audits, as assigned
• Perform activities within the CATSWeb electronic Quality Management System, as required
• Demonstrate commitment to the development, implementation and effectiveness of Sekisui Diagnostics’ Quality Management System per ISO, FDA, and other regulatory agencies
• Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
• Carry out duties in compliance with established business policies
Additional duties, as assigned
• Bachelor’s degree in health science related field is required
• Quality system and quality compliance experience, preferably in a medical device and/or diagnostics manufacturing environment preferred
• Expert knowledge and experience of quality systems, 21CFR part 820 and the ISO 9000 series standards, ISO 13485, cMDR, JPAL
• Excellent organizational and communication (written and oral) skills required
• Technical or scientific background preferred • Knowledge of standards and regulations, product knowledge
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.