Arrotek Medical is a medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. We strive to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package.
For further information on Arrotek Medical, visit
We are currently recruiting for the position of Quality Manager (Maternity Leave Cover).
Responsibilities:
The responsibilities for this position will include the following:
· Overall ownership and management of the Company Quality Management System (QMS).
· Ensure ongoing compliance with ISO 13485, FDA regulations, MDR, ISO 14971 and all applicable regulatory and customer requirements.
· Lead, mentor and develop the Quality team.
· Direct management responsibility for senior quality, quality engineers and quality technicians.
· Ensure all products manufactured meet internal quality standards and customer/regulatory specifications.
· Act as primary quality contact for customers, regulatory bodies, and notified bodies.
· Lead all internal, customer, regulatory and surveillance audits, including preparation, execution, and follow-up.
· Drive effective CAPA, non-conformance, complaint handling and change control processes.
· Provide quality leadership for new product introduction, design assurance, and transfer to manufacturing.
· Ensure effective application of risk management principles in line with ISO 14971.
· Oversee management of quality metrics, trending, and reporting to support continuous improvement and management review.
· Ensure robust document control, record management, and data integrity practices.
· Support manufacturing, engineering and R&D teams on quality-related activities and decision-making.
The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.
Person Specification:
Candidates likely to be called for interview will have most or all of the following:
· Third level qualification (Level 8 or higher) in Quality, Engineering or a Science-based discipline.
· Minimum of 5 years’ in a similar position.
· Proven experience in the medical device industry, with strong working knowledge of FDA regulations and ISO 13485.
· Demonstrated experience leading and developing quality teams.
· Strong background in audit management (internal, customer and regulatory).
· Excellent understanding of CAPA, non-conformance, change control and complaint handling systems.
· Experience supporting design and development activities from a quality and regulatory perspective.
· Strong attention to detail, ensuring high levels of quality at all times.
· Effective communication and cross-functional collaboration skills.
· Strong strategic and problem-solving experience with the ability to multitask and prioritise workload.
· Experience in a fast paced, dynamic role.
Position Details:
This is a full-time position on a Specific Purpose contract covering maternity leave with a view to starting as soon as possible.
Applications:
Interested applicants should submit their up to date CV and Cover Letter to [email protected]. All applications will be treated in strict confidence.
Arrotek Medical is an equal opportunities employer
