Responsibilities
Acting as the focal point for QA in Eastern & Southern Europe, supporting Sales, Service, and Operational teams.
Participating in the maintenance and updating of the QMS, including Site Quality Plans (SQPs), local procedures, and training compliance.
Ensuring understanding and adherence to quality procedures across the Region.
Leading and supporting internal and external 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 quality topics and regulatory expectations.
Driving the CAPA process by identifying quality concerns, conducting spot audits, and ensuring timely corrective actions.
Facilitating regional response to urgent reportability clarification requests raised by the Complaint Handling Unit
Leading or supporting quality improvement projects 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 quality oversight, including Annex Q adherence and audit readiness.
Collaborating with the Supplier Quality team to ensure use of qualified suppliers.
Supporting closure of customer complaints, field actions, and non-conformances.
Participating in remote internal audits as lead 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, Quality, or a related technical field.
Experience in Quality Assurance within the medical device, healthcare, or regulated industry.
Strong knowledge of ISO 13485, EU MDR, and other applicable international regulations.
Experience in internal and external 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 professional certifications (e.g., ASQ CQA, Lead Auditor).
Experience in a regional QA leadership role.
Familiarity with Sales and Service operations in Eastern & Southern Europe.
Experience with CRM systems, field service quality, and digital tools.
Lean/Six Sigma certification or experience with continuous improvement.
Cultural agility and ability to influence across functions and levels.
Willingness to travel across the region as needed.
Pay Range
For Poland based positions, Annual Salary Range: 200,000 PLN - 275,000 PLN
Placement within this range depends on:
Relevant skills and qualifications
Prior job-related 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 align with our internal equity considerations.
Benefits & Rewards
In addition to base salary, our employees have access 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 aligned with performance and company success
The exact benefits package depends on the role, location, and employment terms as specified in the Colleague Value Proposition document that will be shared prior to the interview or at the offer discussion stage.
Performance Bonus: Details to be shared during offer discussions
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Relocation Assistance Provided: No