Description:

Medical Devices QA Lead

Location: Belgium, Braine-l'Alleud

Schedule: Permanent - Full Time - Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently seeking an experienced Medical Devices Quality Assurance Lead.

This position will provide support to operational Quality Assurance activities at key design, development and manufacturing vendors (in the GMP & ISO environment) for development and commercial vendors and specific internal QA support/consultancy for all Medical Devices such as drug delivery devices but more specifically medical mobile apps (Software as medical Devices), sensors and potentially IVDs. This will be achieved through close partnering with QA management at vendors sites and collaboration with Client Technical Operations and other Client teams.

This position will ensure compliance to Medical Devices regulations and GMP compliance of Combination Products from a quality, safety and efficacy point of view.

Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.

Responsibilities

• Design & Development management:
• Provide expert advice, support and management for technical operational QA and general QA matters
• Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
• Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
• Ensure risk assessments are performed at appropriate stages of development and for decision making on issues arising
• Ensure deliverables are issued in accordance with the D&D plan
• Oversee inspection plans at CMO and the Client
• Provide expert support to internal client partners to assure systems are in place to manage novel new drug introducer technologies
• Facilitate investigations and resolution of issues relating to deviation and change management
• Review and approve deviations during D&D activities
• Lead/review critical investigations
• Track CAPA events and closure
• Oversee/track Design change controls
• Ensure application of ISO, MDR and GMP requirements where applicable
• Review and approve Client documentation
• Review and approve submissions and responses
• Review and approve relevant sections of the device Technical Documentation File as required
• Release Clinical Trial Medical Devices
• Ensure Design History File (DHF) is in place
• Accommodate design & technology transfer and ensure systems alignment between vendor and the Client
• Performing focused assessments/audits
• Prepare Quality Agreement
• General QMS:
• Maintain Quality System elements associated with the ISO and GMP activities in a compliant manner
• Drive/Support projects related to quality system improvement
• Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices activities
• Maintain GMP compliance and inspection/audit readiness at all times. Support Commercial QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
• Support Medical Devices related inspections
• Support Management Review Process
• Support Design Reviews

Requirements

• Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position.
• Operational GMP experience or clinical activities experience
• Practical understanding of ISO13485:2016, MDR, ISO14971 and 21CFR820 and part 4 requirements
• US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
• Take accountability for decisions and actions taken.
• Be proactive, confident and enthusiastic during the interaction with colleagues during team work and take the initiative to promote and share/implement best practices.
• Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
• Root cause analysis and risk management/assessment skills will be a distinct advantage.
• Practical experience in development or QA management of Software as Medical Devices, Vital signs Sensors or IVDs
• Practical experience in ISO13485, ISO14971, MDD/MDR and 21CFRpart 820 with main focus on Design Control with either experience with 21CFR part 4 OR Medical Mobile Apps regulation

Our benefits when working in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

If you have the experience needed for this position, please apply directly to

https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001920

If you would like to discuss the role before applying through the website, please contact rocio.egeamota@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE:

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Quality Assurance, Medical Devices, ISO13485, ISO14971, MDD/MDR, 21CFRpart 820

Skills: Medical Device, Quality Assurance Location: Belgium