Will perform some or all of the following: • Contribute to the New Product Design (NPD) process as a subject matter expert in the areas of risk management, design history files, and product requirements • Guide, educate, and influence NPD team members to drive process improvements and reduce compliance risks • Assist in creation and management of risk management files, including annual review process • Assist in creation and management of design history files, including annual review process • Identification of product trends and/or issues for incorporation into NPD, including information gathered in Post-Market Surveillance • Support and participate in the review process for data collection for regulatory filings and product performance claims • Support the inspection readiness program and conduct mock audits, as assigned • Support the corporate auditing function by conducting audits, as assigned • Complete assigned tasks within the electronic learning management system and 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 • Support Environmental Management System (EMS) activities and compliance per ISO14001 • 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 required and a minimum of 6+ years of quality system and quality compliance experience, preferably in a medical device and/or diagnostics manufacturing environment • Expertise in new product design • Expert knowledge and experience of quality systems, 21CFR part 820 and the ISO 9000 series standards, ISO 13485, cMDR, JPAL • 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: • CATSWeb training is preferred • Green and/or Black Belt Certified is a plus • LEAN Manufacturing is a plus • Auditor training is a plus
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.
Additional Salary Information: Sekisui Diagnostics offers a competitive compensation and benefits package.
Internal Number: 1608
About Sekisui Diagnostics
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.