Quality Manager
Hiring: Quality Manager
Are you passionate about quality systems and regulatory excellence in laboratory environments? We're looking for a Quality Manager to lead our clients compliance efforts and drive continuous improvement across our operations.
Your Impact
As our Quality Manager, you will:
- Lead ISO 15189 Quality Management: Maintain and update SOPs, oversee internal audits, and implement corrective actions.
- Champion Compliance: Ensure our lab meets CLIA certification requirements and IVDR standards for diagnostic testing.
- Educate & Empower: Keep the team informed on regulatory changes and foster a culture of quality awareness.
- Collaborate & Innovate: Work closely with lab leadership to develop new procedures and improve existing protocols.
Key Responsibilities
ISO 15189 Quality System
- Maintain and revise quality documentation and SOPs.
- Coordinate internal audits and follow up on corrective actions.
- Identify and implement process improvements.
- Ensure proper documentation and review of quality records.
Training & Awareness
- Stay current with regulatory updates.
- Train staff on QMS and quality control procedures.
- Promote user-centric quality practices across the lab.
CLIA Certification
- Develop a roadmap for CLIA compliance.
- Liaise with regulatory bodies to meet certification requirements.
IVDR Compliance
- Identify tests subject to IVDR.
- Register applicable tests and ensure ongoing compliance.
- Review new tests for IVDR alignment before implementation.
About You
- Proven experience with ISO 15189 quality systems.
- Background in molecular biology or similar lab environments.
- Experience working with Finnish authorities (e.g., FINAS, FIMEA) is a plus.
- Fluent in Finnish and English, both written and spoken.
- Detail-oriented, adaptable, and committed to regulatory excellence.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.