ROLE:
Implement and ensure Quality System Compliance according to ISO 13485, FDA 21 CFR, EU-MDR 745/2017 requirements. Point of contact to authorities as Management Representative Set direction and identify priorities regarding Compliance and Regulatory Requirements for the Biotech Europe site. Employees are expected to support the quality concepts inherent in the business philosophies of Biotech Europe Meditech Inc Ltd, including a variety of job-related tasks which may not be specific to this position profile.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Leadership
* Set Quality Objectives and goals for the Quality Management System and site that are aligned to the site strategy.
* Implement and maintain the Quality Management System in line with ISO 13485, FDA 21 CFR and EU MDR 745/2017 requirements, and other relevant regulatory requirements and ensure that the site is audit ready at all times.
* Ensure that a monitoring system is in place to ensure our Quality Management System is kept in compliance and updated as necessary in line with regulatory changes.
* Ensure quality and regulatory personnel are competent in the activities performed as part of ISO 13485, FDA, MDR and customer requirements.
* Ensure implementation and effective management of Quality Management System elements including: Internal Audit program, Document Control, Change Management, Validation, Non conformance management, CAPA, Deviation, Supplier Management, Risk Management, Complaint Management, Vigilance and Post Market Surveillance:
* Lead on-site regulatory inspections as Management Representative.
* Ensure that requirements related to incoming inspection, in process inspection and product release are implemented and effectively managed.
* Ensure that product packaging, labelling and IFU requirements are understood and implemented and that artwork is kept up to date.
* Ensure that requirements for sterilization of product and environmental monitoring are implemented and effectively managed.
* Ensures that Management Review is performed as required by relevant site procedures.
* Ensures that site Quality metrics and KPI's are developed, reviewed and evaluated
* Leads assigned global quality projects and compliance initiatives where necessary.
* Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
* Provide leadership and development to the organization to maximize effectiveness and assist development of employees concerning the Quality Management System.
* Acts as site responsible person for Vigilance activities including reviewing of complaints for vigilance determination, initiating reporting and vigilance activities.
EDUCATION:
* A level 8 Degree in a Quality, Science or Engineering discipline
EXPERIENCE:
* Excellent working knowledge of Quality System Requirements such as ISO 13485, FDA 21 CFR and the MDR regulations.
* At least 5 years' experience in a senior leadership position.
COMPETENCIES REQUIRED:
* Experience in working in a high volume medical device production facility.
* Strong computer skills - Change control management; Design Control, and process control including the use of automated management systems.
* Certification as an auditor to ISO 13845 is highly desired.
* Good customer relation skills
* Ability to present an independent opinion
* Quality of work / attention to detail; maintains high standards despite pressing deadlines
* Problem Solving (using recognized tools) and decision making (makes sound factual decisions)
* Risk Management including FMEA generation