Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionResponsible for maintenance and improvement of the Quality System in compliance with FDA Medical Device Quality System Regulations (QSR) and ISO 13485 for the U.S. division of IDD. Interpret, provide counsel, and implement regulatory and quality system requirements. Advise management and personnel in order to assure compliance with FDA regulations and cGMP. Recommend remedial actions, and resolve internal issues through education and support of open dialog. Responsible for Quality communications with Centers of Excellence regarding Post Market activities including, but not limited to complaints, MDRs, Recalls, FCAs, CAPAs, Non-conformances and QS issues. Participates in development and approval of Standard Operating Procedures (SOP) across diverse functional areas of the division. Reviews, verifies and guides Document Control in the development, improvement, and maintenance of the internal electronic documentation system. Ensures that procedures and routines related to product inspection and release are in compliance with FDA regulations. Creates and maintains annual audit schedule and performs internal quality audits in compliance with QSR and QMS. Prepare reports on quality system activities, and maintain schedule and reporting requirements for bi-annual QS Management Review meetings. Manage and direct Document and Media Control for the U.S. division including management of areas including but not limited to: SOPs, work instructions, forms, templates, employee training, record retention, change control, customer communications, and other required documentation. Responsible for U.S. CAPA System Quarterly Reviews and reporting. Responsible for maintaining the US-IDD Quality Manual and required Quality Agreements. May also serve as backup for Regulatory Affairs in the event of absence or workload concerns. This may include Regulatory functions such as FDA communications, and guidance to Marketing, Technical Support, Field Service, Customer Service and Distribution on regulatory requirements as it relates to job function. Performs investigations, analyzes data for statistical analysis, supports supplier approval and qualification, and special projects as required. Expected to remain current on existing regulations, new requirements, and industry trends.Key Responsibilities:· Instituting, monitoring, and updating the Quality System at the U.S. division for compliance with FDA QSR, cGMP, and ISO 13485 requirements.· Ensuring that U.S. Standard Operating Procedures and other controlled documents go through periodic review within the electronic document management system, and that training as required by management, is recorded and accounted for.· Ensure the Internal Quality Audit schedule is established yearly, that audits occur as scheduled, and that the audit records and any corrective actions are maintained and reviewed.· Establishing and preparing for bi-annual Quality System Management Review meetings and ensuring appropriate areas are represented.· Instituting, monitoring, and maintaining the U.S. CAPA System through quarterly meetings and ensuring appropriate reporting and review is maintained and documented.· Oversight of post market activities, document control activities, supplier assessments and approvals, statistical analysis including critical metrics, product inspection, and product release.Minimum Requirements/Qualifications:· BA/BS in biology, chemistry, engineering, or other medical device related field.· Ability to manage teams in the implementation of quality plans and programs.· Interpersonal skills and ability to foster teamwork.· Organizational skills, including project management, with attention to details.· Self-directed initiative and ability to communicate effectively in writing.· Four to six years’ experience in quality, preferably in medical devices.· Knowledge and understanding of the Medical Device industry, in vitro diagnostics and related FDA QSR/QMS Regulations.· Experience in auditing quality systems for medical devices.Non-Negotiable Hiring Criteria:· BA/BS in biology, chemistry, engineering, or other medical device related field.· Four to six years’ experience in quality, preferably in medical devices.· Experience in auditing quality systems for medical devices.· Successful management of teams.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
