Head of Quality Assurance

envista· Nobel Biocare AB
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📍 Sweden, Värmland, KarlskogaFull time

About this role


Job Description:

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 

Job Requirements:

  • 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

#LI-PG1

Operating Company:

Nobel Biocare

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Frequently Asked Questions

Is the salary disclosed for the Head of Quality Assurance position at envista?
The salary for this Head of Quality Assurance role at envista is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Head of Quality Assurance position at envista located?
This Head of Quality Assurance role at envista is based in Sweden, Värmland, Karlskoga. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Head of Quality Assurance role at envista full-time or part-time?
This is listed as a Full time position. It is posted as a Head of Quality Assurance role in the Nobel Biocare AB department at envista.
Which team or department does the Head of Quality Assurance at envista belong to?
This Head of Quality Assurance position is part of the Nobel Biocare AB department at envista. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Head of Quality Assurance position at envista?
Click the "Apply Now" button on this page. You will be redirected to envista's official application portal hosted on workday where you can submit your application directly.
When was the Head of Quality Assurance job at envista posted?
This Head of Quality Assurance position at envista was posted on Jul 7, 2026. Apply as soon as possible — early applications are often reviewed first.
Head of Quality Assurance
envista
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