Process Supporter - Medical devices

Denmark; Denmark; Remote; DKK 520,000 - 760,000; Full time

Job summary

Contura International A/S is a Copenhagen-based medical technology company seeking a Process Supporter to bolster product release, drive investigations, and ensure smooth production in a highly regulated environment.

You will join a team of process supporters/engineers, collaborating with QA and RA, and with the operations team to meet deadlines. A background in natural sciences and fluent English are preferred.

Qualifications

• Engineer/chemist/pharmacist/microbiologist or other natural science degree.
• Medical device industry experience preferred.
• Strong problem solving abilities.
• Knowledge of statistics preferred.
• Basic polymer chemistry knowledge is an advantage.
• Strong team player.
• Fluent in English (oral and writing).

Responsibilities

• Drive investigations of non-conformities and ensure timely CAPA implementation.
• Assess, implement and document changes through Change Control system.
• Maintain and improve procedures and work instructions for compliance and efficiency.
• Review batch documentation and support timely product release.
• Collaborate with QA/RA to meet requirements and with the operations team.

Skills

Natural science degree

Medical device experience

Problem solving

Statistics knowledge

Polymer chemistry

Team player

English fluency

Education

Higher education in natural sciences

Job description

Contura International A/S (Contura) is a Copenhagen based medical technology company that develops and manufactures innovative medical products in the fields of orthopaedics, soft tissue augmentation and animal health using its unique, patented hydrogel technology.

The manufacturing facility, which is approved in US, Europe, Canada, Australia, etc., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products. Contura has obtained FDA approval for its product for treating stress urinary incontinence in women, Bulkamid, and a manufacturing license (§39) for production of its hydrogel technology as a medicinal product.

The company’s development, manufacturing and testing processes comply with the European Medical Devices directive 93/42/EEC and the quality system meets the standards required to obtain ISO 13485:2016. The production facility is classified as ISO class 8/GMP class C.

Contura is currently 130+ employees but is growing by the month.

The company offers:

A challenging position in a growing company with dedicated people and a strong pioneer spirit. We reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment.

There is a natural focus on the ongoing development of professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry.

The position:

As a Process Supporter, you will play a key role in supporting product release, driving investigations and changes, and ensuring a smooth production flow in a highly regulated manufacturing environment.

You will be working alongside a larger group of process supporters/engineers who are well versed in the day-to-day flow of production. The tone in the team is informal, but we all take pride in our work and aim to work in an efficient manner to meet agreed deadlines. We like to celebrate our achievements with a glass of champagne, a slice of cake or an ice cream.

Your main responsibility as a process supporter will be, but is not limited to:

• Drive investigations of non-conformities and ensure timely implementation of CAPAs
• Assess, implement and document changes through the Change Control system
• Maintain and improve procedures and work instructions to support compliance and operational efficiency
• Review batch documentation and support timely product release by ensuring documentation is complete and compliant
• Work in close collaboration with QA and RA to meet needed requirements
• Work in close collaboration with operations team

Professional profile/qualifications

• Engineer, chemist, pharmacist, microbiologist or other relevant higher education within natural science
• Medical device industry experience preferred
• Enjoys problem solving
• Knowledge of statistical techniques preferred
• Basic knowledge of polymer chemistry is an advantage
• Strong team player
• Fluent in English (oral and writing)

Personal Profile

As a person you are service minded, and a team player. You thrive in an environment with sharp deadlines and take pride in delivering a solid performance and on-time results. You are analytical and enjoy problem solving and can think out-of-the-box.

The ideal candidate would have a few years of experience within the field, but it is not a strict requirement.

A background from the Medical Device- or Pharma industry would be beneficial. You are able to handle multiple tasks, and you meet agreed deadlines. You are open-minded and enjoy teamwork with colleagues from other departments. You have an eye for detail, are analytical and take independent responsibility for carrying out daily tasks. Your approach to your work is structured and "hands on".

If you have any questions about the position, feel free to contact Katrine Brandt, Associate Manager, at [e-mail]