Head of QA, Medical Device, Carmo / 1865

The Company
Carmo is an expert on injection molding world-wide and a 100 % Danish owned company established in 1940 placed in Espergærde, north of Copenhagen. With a 60-year track record of high-quality injection moulding of highly specialized technical and medical components, they design, produce, and sell quality injection moulded plastic components globally with a significant focus on the Medical Device industry, but not limited to.
Quality, Service and Flexibility are the key words of the production and in all aspects of the interaction with customers. Carmo focuses on minimizing hassle and maximizing service, while helping customers turning ideas into products. Based in Denmark running a highly automated injection moulding production.

By leveraging robotics and vision technology, Carmo delivers components with remarkably high quality due
to their ISO 13485 certification. As market leader in a competitive market, Carmo is known for being up to date within development combined with modern production facilities, putting severe knowhow and experience in ensuring customers an easy integration and stability in their products and production. Please read more www.carmo.dk.

The Team and culture
The QA Team encompassing both the QA and QC area, consists of 14 passionate and skilled individuals who are responsible for ensuring the quality of all products. As a leader, you will guide and support the team using modern methods, going above and beyond to lead and train your colleagues. The team thrives on a strong sense of commitment, cooperation, and a willingness to assist one another when necessary. As a leader, you embody qualities of delegation, open-mindedness, and modern leadership, always seeking smooth collaboration with both colleagues and external stakeholders.

Head of QA, Medical Device

• You are part of the management group; involved in decisions and the strategy
• Leadership, motivation, and development of the QA function
• You join a successful company in continued development

The Challenge
As Head of QA Function, you are responsible for all QA tasks including QC within the company. You must ensure that the area operates optimally, efficiently, and adds value to the company. Your workday will be characterized by many assignments and often presents exiting challenges. The company is developing customized solutions within Medical Devices and therefore you must be skilled within the area and a motivational sparring partner and leader. You have a strategic and a business-oriented mindset without compromising the QA area. You secure optimal communication with external partners and between QA, QC and with other departments including the management group.

In addition to the daily operation, you are also responsible for:

-Leading the team, attracting relevant candidates and ensure continued development
-Prioritizing the QA and QC task portfolio including the daily operation within QC
-Budget related to the area
-Reviewing and approving risk analyses
-Overall responsible for releases, complaints, side effects and recalls
-Overall responsible for approvals of validation, qualification, calibration, and testing
-Ensuring the preparation and maintenance of specifications, instructions, and master files
-Interdisciplinary strategic work within the company
-Ensuring management is informed about the effectiveness and progress of QA´s quality projects
-Reporting significant deviations to management
-Being up to date with regulatory requirements applicable at any time
-Participating in audits and inspections by clients and authorities
-Management representative regarding ISO 13485

Carmo is offering you opportunities for personal development within an international environment.
You will be encouraged and welcomed to bring forth new ideas, discuss concerns and share feedback with colleagues and management. It is this freedom and respect shown to all employees, which makes Carmo an attractive place to work. You will report to the CEO.

Talent
You have minimum 5-10 years’ experience from Quality Assurance, within the Medical Device area. You have solid experience with commercial operations in a customer-oriented environment. You are enthusiastic becoming a leader or you already have a proven leadership record. You have worked with both the QA and QC guidelines related to ISO 13485. Likewise, you see QA in a strategic context with the business for example as Project member for QA related to customer projects. You like and are familiar with collaborating with clients and their QA responsible and team including Regulatory- body.

Your educational background is e.g. master’s degree in engineering, Natural Science or similar.

As a person you are mature, outgoing and with particularly good self-awareness. You are a strong leader who can develop people and the QA area by delegating to your team. Through your “People Skills” and good understanding of relationships, you make things come together in a higher unity, optimizing collaboration within the department and across teams.

You are clear and persistent in your expectations and requirements to quality, while being pragmatic and flexible in your approach. You are initiative-taking and able to work independently and finally you can communicate clearly and thrive in a high impact position. You are of course fluent in Danish and English.

Application
Best Talent is responsible for the recruitment process at Carmo and will be handling your application on a confidential basis. Forward your application in English or Danish marked ”1865/Head of QA” to [email protected]. We will interview candidates ongoing, therefore please apply as soon as possible. You can read more about Best Talent at www.besttalent.dk.