medical device qa lead in dublin

posted
job type
contract
apply now

job details

posted
location
dublin
job category
pharmaceutical
job type
contract
working hours
Full-Time
reference number
KRMDQA
phone
+353 1 402 9541
apply now

job description

We are on the hunt for a to join a Device QA Lead global leader in Biopharmaceuticals!

(16 month initial Contract based in Dublin)

Responsibilities:

* Expert for supplier quality management, responsibility for supplier oversight, implementation of quality agreements and acting as supplier change notification implementation lead across external manufacturers and other service providers
* Direct management of QA specialists, responsible for mentoring & coaching the individuals to support them in their day-to-day roles & their career development
* Lead project activities for new launches and interact with partners
* Accountable for commercial and clinical customer complaints for device and combination products
* Overall responsibility for managing Company's transition to the Medical Device Regulation
* Support regulatory submissions and inspections, and participate in internal and external compliance and for-cause audits as required
* Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business

Qualifications:

* Bachelor's Degree in BS in Engineering or equivalent technical discipline required
* 5 - 7 years of experience working with medical device or combination products in a regulated healthcare industry
* Minimum of 4 years Quality Assurance and/or Quality Engineering
* Expert knowledge of international regulations for Device and Combination Products
* Familiarity with Medical Device Regulation
* Experience with Class I & II & III sterile and non-sterile medical devices
* Experience working with external manufacturing partners
* Experience through interacting and collaborating with cross-functional global teams

APPLY TODAY and take those next steps towards your career goals!!!

Please note: Candidates must hold a full working visa to work in Ireland (min stamp 4 accepted)

Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003