Quality Management Employee

BioTalent; Berlin; Hybrid; EUR 40.000 - 55.000; Vollzeit

Benefits dieser Stelle

30-hour work week

Flexible schedule

Hybrid working model

Annual pay reviews

Yearly bonus scheme

Transport & meal allowance

Free refreshments

Generous holiday entitlement

Supportive team environment

Zusammenfassung

A leading diagnostics manufacturer in Berlin seeks a Quality Management Employee to ensure compliance with ISO standards and maintain quality documentation. The role involves problem-solving, conducting risk assessments, and supporting audits. Applicants should have at least 2 years of relevant experience in the medical device industry. The position offers a hybrid working model with a good work-life balance, flexible hours, and annual bonuses. Join a supportive team that values collaboration and quality.

Qualifikationen

• Minimum of 2 years working in a Quality Management department within a Medical Device or In-Vitro Diagnostics manufacturer.
• Solid understanding of ISO 13485 and ISO 14971 standards.
• Proven ability to create and maintain quality documentation.

Aufgaben

• Ensure full compliance with ISO 13485 quality management standards.
• Create, review, and maintain quality documentation.
• Process and investigate complaints and deviations.

Kenntnisse

Problem-Solving

Attention to detail

Organisational skills

Collaboration

Jobbeschreibung

Senior Recruitment Consultant | 12,000+ Connections | MedTech Specialist - Cardiovascular, Surgical & Commercial | DACH & International Markets

Quality Management Employee (30hr per week)

Location: Berlin, Germany – Onsite, 2 days home office per month

Are you looking to work within an excellent ‘Quality’ department?

We are supporting a leading manufacturer in the in-vitre diagnostics (IVD) sector, committed to developing innovative solutions that simplify diagnostic processes while ensuring sustainability and ease of use. Their product portfolio includes advanced diagnostic kits covering areas such as infectious diseases, prenatal screening, hormone analysis, and oncology markers.

Benefits

• 30‑hour per week contract – Enjoy a healthy work‑life balance with reduced weekly hours
• Flexible schedule – Option to split your hours across 3 or 4 working days per week
• Hybrid working model – Primarily onsite with two home office days per month for added flexibility
• Annual pay reviews
• Yearly bonus scheme – Based on company performance, allowing you to share in their success.
• Transport & meal allowance – €50 per month for gas/transport plus €3.10 daily canteen allowance.
• Free refreshments – Complimentary fruit, tea, coffee, and more
• Generous holiday entitlement – 24 days of paid vacation per year
• Supportive team environment – Work in a collaborative and friendly atmosphere that values your input

Tasks

• Ensure full compliance with ISO 13485 quality management standards throughout all processes.
• Create, review, and maintain quality documentation (SOPs, work instructions, records) to meet regulatory (IVDR) and internal requirements.
• Process and investigate complaints and deviations, performing thorough root cause analysis and documenting findings.
• Manage Corrective and Preventive Actions (CAPA), including planning, implementation, and effectiveness checks.
• Plan, coordinate, and execute validation activities, including equipment and process validation.
• Conduct risk analysis and risk assessments in accordance with ISO 14971, ensuring proactive identification and mitigation of potential hazards.
• Support internal and external audits and inspections, ensuring timely closure of findings.
• Collaborate with cross‑functional teams to maintain compliance and continuous improvement in quality systems.
• Monitor and report on quality performance metrics, driving initiatives for improvement.

Your Profile

• Experience: Minimum of 2 years working in a Quality Management department within a Medical Device or In‑Vitro Diagnostics (IVD) manufacturer.
• Regulatory Knowledge: Solid understanding of ISO 13485 and ISO 14971 standards.
• Documentation Skills: Proven ability to create, review, and maintain quality documentation (SOPs, work instructions, records).
• Problem‑Solving: Experience handling complaints, deviations, root cause analysis, and managing CAPA processes.
• Validation & Risk Management: Familiarity with process validation and conducting risk assessments.
• Technical Competence: Comfortable working with quality systems and tools for compliance and continuous improvement.
• Location: Ability to work onsite in Berlin.
• Soft Skills: Strong attention to detail, organisational skills, and ability to collaborate effectively in a team environment.

For more information or to apply, please contact Luke Fines at BioTalent with a copy of your CV.