Sales Manager, Engineering Services
Your Role
In this key quality role, you will be primarily responsible for supplier quality management and maintaining the Quality Management System (QMS). Your main focus will be ensuring that our suppliers, components, and materials meet quality requirements and applicable standards. You will also ensure that our QMS documentation and records management procedures comply with industry standards and oversee internal QMS audits.
The specific responsibilities and scope of the role will be tailored to the selected candidate´s expertise and experience.
Key Responsibilities
Lead and further develop the companys Supplier Quality Management processes in accordance with ISO 13485, MDR, and FDA requirements.
Qualify, evaluate, and monitor suppliers through activities such as supplier audits and performance reviews.
Manage supplier-related nonconformities, corrective and preventive actions (SCARs), and risk assessments.
Collaborate closely with Operations and R&D to ensure effective supplier partnerships.
Review and approve supplier documentation such as specifications, validations, and certificates.
Support incoming inspection and component qualification activities.
Drive continuous improvement initiatives related to supplier performance and supply chain quality.
Maintain and update QMS documentation and records.
Coordinate and conduct internal audits.
Contribute to external audits and regulatory inspections.
Support overall QMS activities as required.
What We Expect From You
You have a bachelors or masters degree in engineering or a related field
You have several years of experience in quality assurance or supplier quality within the medical device industry or a similarly regulated environment
You have strong knowledge of ISO 13485, FDA 21 CFR 820, and related regulatory requirements
You are experienced with supplier audits, supplier development, and quality tools.
You have good analytical thinking and problem-solving skills.
You have strong communication and collaboration skillsin both Finnish and English
You have good documentation skills in Finnish and English
You have ability to work independently and manage multiple priorities
You have ISO 13485 or ISO 9001 internal auditor training or certification
What We Offer
A key role in a growing international medical device company
The opportunity to shape and improve supplier quality processes
Collaboration with skilled cross-functional teams
Meaningful work contributing to products that improve patient safety and well-being
Competitive compensation and benefits
The position is located in Tampere, with the possibility for occasional remote work