Senior Quality Assurance Engineer

Nobel Biocare; Karlskoga kommun; On-site; SEK 550,000 - 750,000; Full time

Job summary

Nobel Biocare AB in Karlskoga is seeking a Quality Assurance Engineer to lead the development and implementation of the quality management system in line with FDA regulations and ISO13485. You will ensure processes and procedures secure quality and regulatory compliance for site products.

The role involves supporting audits, investigating non-conformances, driving corrective and preventive actions, and promoting a quality culture across the site and with sister sites, the distribution center,

Qualifications

• Experience from production and process industry.
• B.SC, M.SC or equivalent work experience in relevant area.
• Knowledge on Continuous Improvement.
• Experience in driving Quality culture.

Responsibilities

• Develop and implement the QMS according to FDA regulation, ISO13485 and other applicable Quality system regulations.
• Support audits and investigations of non-conformances.
• Secure implementation of corrective and preventive actions.
• Collaborate cross-functionally with site departments, sister sites, distribution center and Head Office.

Skills

Swedish & English

Communication skills

Analytical skills

SPC / Statistical methods

Education

B.SC, M.SC or equivalent

Tools

SPC

Job description

Responsible for the process related Quality Management and Quality Assurance at the production site of Nobel Biocare AB, located in Karlskoga. The position shall ensure that processes and procedures, including ISO13485 and FDA QMSR , needed for securing quality and compliance for the manufacturing of the site products are supported. The position also engages in continuous improvement and supports the awareness of GMP at the site. Additionally the position in it’s responsibilities and accountabilities cooperates crossfunctionally with the site departments, sister sites, our distribution center as well as the Head Office.

Job Requirements

The Quality Assurance Engineer participates in the development and implementation of the QMS according to current FDA regulation, ISO13485 standard and other applicable Quality system regulations. This position in Quality Assurance is responsible for supporting or taking active part in audits, to secure investigations of non-conformances, secure implementation of corrective and preventive actions as well as be part of developing the processes with in Quality.

Critical Knowledge And Qualifications

• Experience from production and process industry
• B.SC, M.Sc or equivalent work experience in relevant area
• Knowledge on Continuous Improvement
• Experience in driving Quality culture

Critical Skills/technical Know-how

• Fluency in Swedish and English, both spoken and written
• Well developed communication skills
• Analytical ability to evaluate information and decision making

Critical Experience

• More than 5 years experience in regulated process industry or equivalent experience
• experience in Quality Assurance work in industries such as medical device, pharmaceutical or food industry
• Good ability to cooperate in a matrix organization

Additional experience in Statistical process analysis and/or SPC is an advantage

Operating company:Nobel Biocare