Quality Engineer

Navinci Diagnostics AB; Uppsala kommun; On-site; SEK 520,000 - 760,000; Full time

Job summary

Navinci Diagnostics AB is seeking a hands-on Quality Engineer to perform and supervise laboratory-based QC activities, ensuring product quality, safety, and regulatory compliance throughout the manufacturing lifecycle.

The role involves routine testing of materials and products, developing QC lab operations, and collaborating with Production, R&D, and Quality Assurance to resolve issues and drive continuous improvement.

Qualifications

• Bachelor's or Master's in chemistry, biotechnology, pharmaceutical sciences, or related field.
• Minimum 2 years’ experience in ISO-standard laborator environment.
• Hands-on experience with immunostaining, immunoassays, antibodies, microscopy, or related technologies.

Responsibilities

• Perform routine QC testing of raw materials, semi-finished and finished products.
• Coordinate daily QC laboratory operations for timely, accurate testing.
• Maintain adherence to laboratory safety standards and QMS requirements.
• Develop, review, and maintain SOPs, analytical methods, and quality documentation.
• Act as QC representative during transfer of new products from R&D to manufacturing.
• Drive CAPA, deviations, and change control processes; monitor product quality.

Skills

Immunostaining

Immunoassays

Microscopy

QMS & GMP/ISO

Regulatory knowledge

Problem solving

Cross-functional collaboration

Technical leadership

Education

Bachelor's or Master's in Chemistry/Bi Biotechnology/Pharmaceutical Sciences

Job description

We are looking for a hands-on and experienced Quality Engineer to execute and oversee laboratory-based QC activities.

The Quality Engineer plays a critical role in ensuring product quality, safety, and compliance throughout the entire manufacturing lifecycle. This position is responsible for performing routine testing, developing QC laboratory operations and ensuring that Navincis products meet established quality standards and regulatory requirements. Acting as a subject matter expert, the role supports new product introductions and collaborates closely with cross-functional teams—including Production, R&D, and Quality Assurance—to resolve quality issues and drive continuous improvement.

Perform routine quality control testing of raw materials, semi-finished goods, and finished products according to established procedures.

Coordinate daily operations within the QC laboratory, ensuring timely and accurate testing of materials and products.

Maintain strict adherence to laboratory safety standards and Quality Management System (QMS) requirements.

Develop, review, and maintain SOPs, analytical methods, and quality documentation.

Act as the QC representative and subject matter expert during transfer of new products from R&D to manufacturing.

Collaborate closely with Production, R&D, and Quality Assurance teams to troubleshoot and resolve quality issues.

Drive continuous improvement initiatives, including CAPA, deviations, and change control processes.

Monitor product quality performance throughout the product lifecycle.

Train and mentor new QC staff to ensure adherence to best laboratory practices and procedures.

Support pilot production, process validation, and scale-up activities.

Participate in risk assessments and initiatives to enhance operational and product quality.

Perform time-to-time given tasks given by the Director of Operations.

About the Role

We are looking for a hands-on and experienced Quality Engineer to execute and oversee laboratory-based QC activities.

The Quality Engineer plays a critical role in ensuring product quality, safety, and compliance throughout the entire manufacturing lifecycle. This position is responsible for performing routine testing, developing QC laboratory operations and ensuring that Navincis products meet established quality standards and regulatory requirements. Acting as a subject matter expert, the role supports new product introductions and collaborates closely with cross-functional teams—including Production, R&D, and Quality Assurance to resolve quality issues and drive continuous improvement.

Perform routine quality control testing of raw materials, semi-finished goods, and finished products according to established procedures.

Coordinate daily operations within the QC laboratory, ensuring timely and accurate testing of materials and products.

Maintain strict adherence to laboratory safety standards and Quality Management System (QMS) requirements.

Develop, review, and maintain SOPs, analytical methods, and quality documentation.

Act as the QC representative and subject matter expert during transfer of new products from R&D to manufacturing.

Collaborate closely with Production, R&D, and Quality Assurance teams to troubleshoot and resolve quality issues.

Drive continuous improvement initiatives, including CAPA, deviations, and change control processes.

Monitor product quality performance throughout the product lifecycle.

Train and mentor new QC staff to ensure adherence to best laboratory practices and procedures.

Support pilot production, process validation, and scale-up activities.

Participate in risk assessments and initiatives to enhance operational and product quality.

Perform time-to-time given tasks given by the Director of Operations.

• Perform routine quality control testing of raw materials, semi-finished goods, and finished products according to established procedures.
• Coordinate daily operations within the QC laboratory, ensuring timely and accurate testing of materials and products.
• Maintain strict adherence to laboratory safety standards and Quality Management System (QMS) requirements.
• Develop, review, and maintain SOPs, analytical methods, and quality documentation.
• Act as the QC representative and subject matter expert during transfer of new products from R&D to manufacturing.
• Collaborate closely with Production, R&D, and Quality Assurance teams to troubleshoot and resolve quality issues.
• Drive continuous improvement initiatives, including CAPA, deviations, and change control processes.
• Monitor product quality performance throughout the product lifecycle.
• Train and mentor new QC staff to ensure adherence to best laboratory practices and procedures.
• Support pilot production, process validation, and scale-up activities.
• Participate in risk assessments and initiatives to enhance operational and product quality.
• Perform time-to-time given tasks given by the Director of Operations.

What We Are Looking For

Education and background

• Bachelor’s or master’s degree in chemistry, Biotechnology, Pharmaceutical Sciences, or a related field.
• Minimum 2 years’ experience working in ISO standards laboratory environment.

Experience

• Hands-on experience with immunostaining, immunoassays, antibodies, microscopy, or related technologies is required.
• Knowledge and working with Quality Management Systems (QMS) and regulatory requirements (e.g., GMP, ISO standards).

Skills and Personal attributes

• Excellent problem-solving and communication skills.
• Technical leadership and cross-functional collaboration skills.
• Precision, quality awareness, responsibility, engagement, reliability and flexibility are important personal characteristics.
• Ability to manage multiple priorities in a fast-paced environment.

Applications are reviewed on an ongoing basis and interviews will be conducted continuously throughout the recruitment process