Snr Manager, Market Quality Europe

Proclinical is advertising a vacancy for a Senior Manager, Market Quality Europewith a global technology company entering the medical device space. The position, which is based in the Netherlands, offers an exciting opportunity to join an innovative and entrepreneurial organisation to provide expertise and bolster a career in the medical device sector.

Job Responsibilities:

• Promoting correct standards of quality within the designated region by influencing and managing all quality related activities.
• Working closely with the Director, Business & CLS Quality to develop and implement Quality strategy and provide strategic leadership to the designated region.
• Interacting with and providing oversight to local operating companies to ensure adherence to QMS.
• Serving as the EU Authorized Representative for compliance with EU MDR.

Skills and Requirements:

• Bachelor's degree in an engineering or science field required.
• Advanced degree preferred (e.g. MS, MBA).
• Minimum of 10+ years of experience in medical device field.
• 5 years in a LOC/Affiliate/Business Quality role at a manager level preferred.
• Professional certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma would be preferred.
• Demonstrated experience building strong relationships with key business partners and working together to meet quality objectives.
• Strong experience within a global organization in a quality leadership role including leading cross-site and multifunctional organizations.
• Demonstrated experience in stakeholder management and the ability to effectively collaborate across a global organization.
• Demonstrated experience with Health Authority Inspections and audits (e.g.MHRA).
• Supports the implementation and maintenance of local processes that describe the creation and management of local procedural documents in line with global and local regulatory requirements.
• Demonstrated knowledge of quality systems and other standards including ISO 13485, ISO 9001, FDA QSR, etc…
• Strong knowledge of good manufacturing practices and good documentation practices.
• Demonstrated experience handling product recalls, complaints, and field actions investigations.
• Strong experience with local relabelling and repackaging, local supplier quality, distribution and warehouse quality.
• Expertise in CAPA activities in regards to complaints, recalls, and other related non-conformances.
• Experience providing Quality strategies for product registrations and product flow.
• Must have the ability to be an EU authorized representative (EC Rep) and as such be able to assist with Incident and Field Safety Corrective Action (FSCA) reporting in cooperation with you and your distributors.
• Prior experience acting as EU Authorized Representative.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Josh Volpe at +44 203 800 1292 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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