Medical Device Compliance, Systems and Engineering Change Support Administrator at Accora
Cambridge, United Kingdom
Job Descrption
At Accora, we create and develop assistive medical devices to help people lead as full and safe a life as possible.
We are looking for a full-time creative and hands-on medical device compliance, systems and engineering change support administrator to become an integral part of our Product Management Team. This team manages current products and focuses on product improvement, value improvement, engineering change and product systems.
This role is a unique opportunity for a creative, hands-on professional who is deeply passionate about systems and compliance within the medical equipment sector.
Key responsibilities, duties and tasks:
Creating, updating and maintaining medical device build specifications, designs and documentation including written specifications, labelling and User Manuals ensuring that all documentation complies with internal procedures and International Standards.
Investigate, identify, and rectify product and process or system issues in NetSuite and DemandCaster, balancing both reactive and proactive approaches.
Lead and manage projects implementing product changes while assessing effects from these changes and implementing necessary actions with global suppliers, warehousing and distribution partners.
Collaborating with global suppliers to resolve design or build issues and to finalise designs for manufacture ensuring efficiency and quality.
Conduct thorough product and manufacturing nonconformity investigations to maintain our high standards.
Working closely and supportively with our Sales and Purchasing functions to resolve technical product questions and to specify custom, special or modified parts.
General expectations:
Maintain personal and professional development to meet the changing demands of the job and participate in appropriate training activities.
Undertake such other duties, training and/or hours of work as may be reasonably required and which are consistent with the general level of responsibility of this job, whether that be on-the-job training, in-house training or external training courses.
Adhere to relevant Quality and Regulatory requirements at all times.
Undertake health and safety duties commensurate with the post and as detailed in the Company’s Health and Safety Policy.
Act as an ambassador of the Company and promote the company brand, always displaying a positive image to customers and members of the public.
Live and breathe our core values – insight, determination and integrity; deliver to our mission statement and promote the Company’s long-term vision.
Requirements
Experience and knowledge:
It is highly desirable, but not essential, that the applicant has NetSuite and/or DemandCaster experience, training or qualification.
Skills and abilities:
It is essential that the postholder has excellent English communication skills, both spoken and written; essential for report writing and understanding medical regulatory standards.
Benefits
A company laptop to support your design and development work.
Generous annual leave entitlement of 25 days plus public holidays, allowing for a healthy work-life balance.
Optional comprehensive private medical healthcare cover, ensuring peace of mind for you.
Free hot/cold drinks and snacks daily, and free hot lunch every Friday as a token of appreciation for your hard work and dedication.
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