Intersurgical is Europe’s leading designer, manufacturer and supplier of a wide range of medical devices for respiratory support. With over 40 years’ experience in this area, we understand the changing and challenging environment and needs of our customers. Innovation is an important aspect of our business in all areas, where quality is built-in from concept through to final product.
An exciting opportunity has arisen to join our thriving Medical Device Manufacturing Company and support our Strategic Development Programme.
Job Description
An exciting and unique opportunity has arisen for a Quality Compliance Manager to join our thriving medical device manufacturing company Driven by Quality, Defined by Innovation, Built on Trust.
This role sits within our Quality and Regulatory Affairs Department in a highly regulated environment, focusing on compliance and continuous improvement.
We are seeking a proactive and detail-oriented professional to ensure that our Quality Management Systems, including all processes and procedures, complies with regulatory requirements while being effectively implemented.
Key Responsibilities
- Lead and manage internal and supplier audits to ISO 13485, EU MDR, MDSAP and other applicable standards and regulations.
- Oversee the preparation and execution of external audits and regulatory inspections.
- Initiate and manage CAPA and Change Control projects to resolve quality and compliance issues efficiently.
- Collaborate with cross-functional teams including R&D, manufacturing, distribution, quality assurance, and regulatory affairs to achieve compliance objectives.
- Review and approve quality documentation, including procedures and process maps, ensuring continuous improvement and efficiency.
- Stay up to date with regulatory changes, advising the organisation on necessary adjustments to maintain compliance.
- Provide direct support and guidance to teams, suggesting and assisting with the implementation of improvements.
- Work in liaison with strategic programmes to ensure Group QMS compliance across Intersurgical manufacturing sites and subsidiaries, implementing global policies and conducting audits.
Essential Experience & Qualifications
- Higher education
- Experience in an administrative role within an office environment
Desirable Experience & Qualifications
- Experience in quality management or regulatory compliance
- Knowledge of industry standards and regulations
Key Skills & Attributes
- Fluent in English and Lithuanian (verbal and written)
- Proficient in Microsoft Office
- Strong administrative and organisational skills
- Ability to build strong working relationships across departments
- Resilient under pressure, capable of meeting deadlines
- Ability to multitask and prioritise workload effectively
- Self-motivated with a proactive and solution-driven approach
- Strong attention to detail with a methodical and structured mindset
- Excellent problem-solving skills
- Enthusiastic with a can-do attitude
Why Join Us?
- Engaging and impactful work in the medical device industry
- Supportive and friendly work environment
- Competitive salary €4,000 – €5,500 (gross), depending on experience and qualifications
If you are passionate about quality and compliance and want to make a difference in the medical device sector, we encourage you to apply!
