Head of Quality Assurance

The Head of Quality Assurance is responsible for Quality Assurance and Quality Control at the production site of Nobel Biocare AB, located in Karlskoga, Sweden. This position ensures the manufacturing site complies with applicable international medical device regulations and standards. A key responsibility will be to lead, maintain, and continuously improve the site Quality Management System (QMS) to guarantee product safety and efficacy. This role focuses on ensuring that production processes remain in a state of control, validations are robust, and processes consistently produce medical devices that meet specifications, Regulatory requirements (ISO 13485 / FDA 21 CFR 820), and patient safety standards.

• Lead and develop the Quality department consisting of QC and QA

• Ensure the awareness of applicable Regulatory & QMS requirements throughout the organization

• Ensure process risk assessment files are in accordance to ISO 14971

• Ensure validations are robust, monitoring activities are performed and analyzed and oversee revalidation cycles

• Ensure manufacturing process changes are properly assessed

• Partner with manufacturing engineering to optimize inspection and testing methods

• Supervise incoming inspection as well as final product release including Device History Records (DHR)

• Ensure timely resolution of Corrective and Preventive Actions (CAPA)

• Oversee the document control and training processes at the site

• Act as the primary site contact for internal and external audits

• Proven expertise in design and implementation of Quality processes into a manufacturing organization in a regulated industry

• Experience with the development of an organizational culture that promotes and sustains Quality

• Strong proficiency in validation methodologies (process, software, sterilization)

• Practical experience with risk management tools (f.e. PFMEA)

• Strong leadership and ability to influence cross-functional teams (f.e Manufacturing, R&D)

• Objective problem-solving skills with the ability to make firm, risk-based quality decisions under pressure

• High level of attention to detail and scientific rigor

• Fluency (oral and written) in English is mandatory, Swedish is welcome

• Sound SAP system understanding is a plus

• More than 5 years experience in regulated process industry

• Professional experience in Quality Management in industries such as medical device, pharmaceutical or food industry

• Experience in Management positions