Senior Compliance & Quality Lead, EMEA

Medtronic; Netherlands; On-site; EUR 65,000 - 98,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Job summary

Medtronic in the Netherlands is seeking a Sr. Process Compliance Specialist within the Service & Repair (S&R) EMEA organization to elevate compliance across the region.

You will drive quality systems, CAPA, change control, and regulatory readiness to enable cross-functional success. The role requires a bachelor's degree with 4+ years of relevant experience (or a master's with 2+), experience in medical devices, and fluent English.

Qualifications

• Bachelor's degree with a minimum of 4 years of relevant experience, or a Master’s degree with a minimum of 2 years of relevant experience in Quality, Compliance, or Process Improvement
• Experience in medical device or similarly regulated industry
• Fluent written and spoken English language
• Experience in planning, coordinating, communicating, influencing, achieving milestones, resolving issues

Responsibilities

• Ensure ongoing compliance of the S&R EMEA Organization to requirements originating from applicable Quality standards, regulations & policies
• Facilitate Compliance Management reviews at prescribed intervals each fiscal year to review the continuing suitability, adequacy, and effectiveness of the S&R EMEA Organization’s Compliance strategies and programs
• Provision of relevant information and data to S&R EMEA management, that facilitates evaluation of the adequacy and effectiveness of current compliance strategies and programs
• Monitor compliance metrics and identify improvement opportunities
• Collect and analyze data to identify root causes of compliance issues and performance shortfalls
• Ensure timely and effective follow up of compliance actions (e.g. CAPA, Change Control, Regulatory actions etc.)
• Act as a Compliance SME ensuring a first-time right approach to activities affecting compliance to requirements
• Support compliance audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits
• Prepare reports and/or necessary documentation to meet requirements and ensure applicable (internal and external) stakeholders are adequately informed
• Plan, perform, and implement process improvement initiatives to enhance compliance and operational efficiency

Skills

Quality management

Cross-functional collaboration

Regulatory compliance

Project management

Education

Bachelor's degree

Master's degree

Tools

MAP Agile

CAPA

Audit readiness

Job description

Medtronic in the Netherlands is seeking a Sr. Process Compliance Specialist within the Service & Repair (S&R) EMEA organization to elevate compliance across the region.

You will drive quality systems, CAPA, change control, and regulatory readiness to enable cross-functional success. The role requires a bachelor's degree with 4+ years of relevant experience (or a master's with 2+), experience in medical devices, and fluent English.