Exciting opportunity for experienced Quality professionals to lead Quality team at our Roscommon, Ireland facility.
- Ideal for candidates with 15 - 18 years of experience in pharma or medical device manufacturing seeking international leadership exposure.
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.
Leadership
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- 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.
Important Links:.
Website: LinkedIn: Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.
(ref:iimjobs.com)
