GrandVision is a global leader in optical retailing and delivers high quality and affordable eye care to more and more customers around the world. The high quality eye care offered by GrandVision includes a wide range of services provided by its vision expert, prescription glasses including frames and lenses, contact lenses and contact lens care products, and sunglasses both plain and with prescription lenses. These products are offered through leading optical retail banners which operate more than 40 countries across Europe, the Americas, the Middle East and Asia. GrandVision serves its customers in over 7,000 stores and with more than 37,000 employees which are proving every day that in EYE CARE, WE CARE MORE.
Some key figures:
Our vision is to provide high quality and affordable eye care to more and more people around the world. By doing so, GrandVision aspires to help them realize their full potential in life.
Developing Careers & Potential
Within all GrandVision companies we recruit for a career, not just a job. We are passionate about customer satisfaction and develop our people to look for growth potential within the job and within the company. Our preference is to always promote internally where possible. So, wherever people start, there’s always somewhere else to go. We strive for continuous improvement and our new recruits help us to further raise the future potential of our company. Our whole business is full of people who have gone on to achieve a successful career through experiencing a variety of different roles in different locations and area of our business. We continually support and develop our people who have the desire, ambition and potential to grow.
With customers, stores and employees located in over 40 countries, GrandVision shows diversity to be at the core of its success. Grandvision is a global company proud and committed to be an equal opportunity employer.
QARA Certification Manager (HQ) – Based in Schiphol, Amsterdam – Permanent
The vacancy is part of the GrandVision HQ, Global Quality Assurance and Regulatory Affairs Department.
Department Vision: Continuously enhance business capabilities by using quality management and regulatory compliance as a tool for competitive advantage.
Department Mission: Develop global processes aimed to achieving streamlined and compliant business operations, both internally at GrandVision and in the interaction with suppliers.
Solid reporting line to the QARA Process Manager.
Note that the reporting line may evolve in the future.
None currently; likely to change in the future.
Main purpose of the role
The person appointed for this role is responsible for supporting HQ to define and implement required quality processes to achieve ISO 13485 certification and compliance to applicable regulations.
The person appointed for this role will have to monitor the development of the HQ Quality Management System, assuring that the Global QARA compliance strategy is followed.
Key responsibilities of the role include:
· Oversee the implementation of the GrandVision local Quality Management System in the HQ.
· Review processes and procedures and advise prior to implementation.
· Ensure HQ compliance to the applicable regulations.
· Ensure localization and implementation of the global quality standards & certifications adopted by GV.
· Travel to HQ locations (mostly Montigny, France) for periodic project reviews.
· Monitor maturity and performance of the HQ’s local QMS.
· Support HQ during audits and corrective action plans definition.
· Ensure that deadlines for ISO 13485 certification are met.
· Regularly report to HQ QARA on the status of the Local QMS and relevant QARA KPIs.
· Ensure QARA KPIs are achieved.
· Support the QARA team when and where required.
Key performance indicators
GrandVision Quality and Regulatory Maturity Level Standard
Quality and Regulatory audit results
Achieving and maintaining ISO 13485 certification
Required qualifications/level of education
· Academic degree in Engineering, Science, Quality & Regulatory, Law or Philosophy.
· A minimum of 6 years in a regulated industry, 3 of which (minimum) in QARA.
· Demonstrated ability of having achieved ISO 13485 certificate (or having passed an FDA inspection) in a previous role.
· In-depth knowledge of ISO 13485, EU 2017/745 or 21 CFR 820 is required.
Core competencies/ Personal attributes
· Strong but fair and data-driven personality.
· Ability to prioritize workload.
· Willingness to work hands-on with procedures and records.
· Ability to distill information and take agreed decisions when dealing with conflicting stakeholders.
· Strong planning, problem analysis and resolution, and organizational skills.
· Detect deviations from intended workflows and processes, with exceptional attention to details.
· Learn quickly and effectively, approaching new challenges by taking initiative.
· Scope, manage and prioritize multiple small projects simultaneously.
· Effectively present information to others, including senior management of GrandVision and its subsidiaries.
· Communicate clearly with all areas of the business and maintain inter and intra departmental relationships.
· Team-oriented with strong leadership and interpersonal skills.
· Able to effectively adapt to change (environment, requirements, roles, objectives).
· Demonstrated leadership and change management ability.
Key skills, knowledge and experience
The ideal candidate shall:
· Be able to interpret regulations.
· Have previous experience in a similar role in the medical device or pharmaceutical industry.
· Be comfortable with a pragmatic approach to regulations.
· Be able to manage complex projects.
· Be willing to take on board new challenges with enthusiasm and professionality.
· Be fully proficient in English, particularly written, and Microsoft Office.