QA Design Specialist - Life Sciences (On-Site Sweden)

Dormont Manufacturing Co; Ängelholms kommun; On-site; SEK 450,000 - 600,000; Full time

Job summary

Dormont Manufacturing Co is looking for a Quality Assurance Design Specialist to join their team in Ängelholm, Sweden. This role is crucial for ensuring compliance with design control and product life cycle management, working closely with R&D, operations, and regulatory affairs.

The ideal candidate will have a University Degree in Science or Technology and experience in document control and risk management. Proficiency in English is required, and fluency in Swedish is preferred. Enjoy a collaborative environment where every voice matters.

Qualifications

• One year of experience with document control, change control, and risk management activities.
• Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, IVDR.
• Ability to work effectively with R&D, operations, and regulatory affairs.

Responsibilities

• Ensure implementation of design control processes across new product development.
• Collaborate closely with stakeholders for quality assurance throughout the development process.
• Maintain document control processes for quality and technical documentation.

Skills

Document control

Change control

Risk management

Communication skills

Problem-solving skills

Fluent English

Fluent Swedish

Education

University Degree in Science, Technology or equivalent

Job description

Dormont Manufacturing Co is looking for a Quality Assurance Design Specialist to join their team in Ängelholm, Sweden. This role is crucial for ensuring compliance with design control and product life cycle management, working closely with R&D, operations, and regulatory affairs.

The ideal candidate will have a University Degree in Science or Technology and experience in document control and risk management. Proficiency in English is required, and fluency in Swedish is preferred. Enjoy a collaborative environment where every voice matters.