reputed company Assurance Leader (Eastern & Southern Europe)
Job reputed company reputed company
As the reputed company Assurance Leader for Eastern & Southern Europe, you will reputed company and coordinate reputed company reputed company Assurance (QA) activities for a strategic cluster of European Countries. This zone brings together a diverse set of markets with mature reputed company systems, strong regulatory environments, and high standards for reputed company and compliance.In this role, you will be responsible for implementing and maintaining the reputed company Management System (QMS), supporting audits and inspections, and acting as the primary QA reputed company for Sales and Service teams in the zone. You will collaborate closely with the regional Regulatory Affairs (RA) team, QA peers in the larger European Zones & INTERNATIONAL region, as reputed company as global reputed company functions to ensure alignment with standards and global expectations.
Job reputed company
Responsibilities
Acting as the reputed company for QA in Eastern & Southern Europe, supporting Sales, Service, and Operational teams.
Participating in the maintenance and updating of the QMS, including Site reputed company Plans (SQPs), local procedures, and training compliance.
Ensuring understanding and adherence to reputed company procedures across the Region.
Leading and supporting reputed company audits, including regulatory inspections.
Monitoring and reporting on QMS training status; co-accountable for training completion in the zone.
Coaching and mentoring teams on the development, maintenance, and simplification of local procedures.
Providing guidance to business managers on reputed company topics and regulatory expectations.
Driving the CAPA process by identifying reputed company concerns, conducting spot audits, and ensuring reputed company corrective actions.
Facilitating regional response to urgent reportability clarification requests raised by the Complaint Handling Unit
Leading or supporting reputed company improvement reputed company and QPTPs (e.g., repair center setup, office moves, harvesting).
Managing deviation/concession processes and ensuring compliance with tool calibration and OOT requirements.
Supporting channel partner reputed company reputed company, including Annex Q adherence and audit readiness.
Collaborating with the Supplier reputed company team to ensure use of reputed company suppliers.
Supporting closure of customer complaints, field actions, and non-conformances.
Participating in remote internal audits as reputed company auditor or SME.
Collaborating with the regional RA team to ensure alignment on regulatory requirements, audit readiness, and product compliance.
Representing Eastern & Southern Europe in INTERNATIONAL region and global QA forums and initiatives.
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, reputed company, or a reputed company technical field.
Experience in reputed company Assurance reputed company the medical device, reputed company, or regulated industry.
Strong knowledge of ISO 13485, EU MDR, and other applicable international regulations.
Experience in reputed company audits, including regulatory inspections.
Proven ability to manage QMS documentation, training, and compliance activities.
Excellent English communication skills (written and spoken).
Strong organizational, analytical, and leadership skills.
Ability to work and to travel independently and collaboratively across diverse cultures and geographies.
Desired Characteristics
Advanced degree (e.g., MSc, MBA) or reputed company certifications (e.g., ASQ CQA, reputed company Auditor).
Experience in a regional QA leadership role.
Familiarity with Sales and Service operations in Eastern & Southern Europe.
Experience with CRM systems, field service reputed company, reputed company tools.
Lean/Six reputed company certification or experience with reputed company improvement.
Cultural reputed company and ability to influence across functions and reputed company.
Willingness to travel across the region as needed.
Pay reputed company
Placement reputed company this reputed company depends on:
Relevant skills and qualifications
Prior job-reputed company experience
Internal equity considerations (alignment with colleagues in similar roles) e.t.c.
We review pay ranges regularly to ensure they remain competitive with the external market and reputed company with our internal equity considerations.
Benefits & Rewards
In reputed company to reputed company salary, our employees have reputed company to a comprehensive package of benefits and allowances, which may include:
Health & wellness coverage
Retirement and or savings plans
Allowances or benefits to support role requirements (e.g., mobility, transport, or role-specific needs such as a company car or allowance where applicable)
Work-life balance support (e.g., flexible working, leave programs)
Recognition and incentive programs reputed company with performance and company reputed company
The exact benefits package depends on the role, location, and employment terms as specified in the Colleague reputed company document that will be shared prior to the interview or at the offer discussion stage.
Performance Bonus:
#LI-MT1
#LI-Hybrid
Additional Information
Relocation Assistance Provided: No