Quality Assurance Engineer

SWE - Karlskoga - Nobel Biocare AB R5027433 Sweden Quality and Regulatory Affairs Job description The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently produce medical devices that meet specifications. This role supports and ensures compliant execution of New Product Introduction and manufacturing Life Cycle Management activities and drive continuous improvement activities. Accountabilities

• Ensure process risk assessment files are in accordance with ISO 14971.
• Ensure validations and verifications are robust, monitoring activities are performed and analyzed and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Monitor and track non-conformances, and lead continuous improvement projects.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document and evaluate production non-conformances, and drive root cause analysis.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action (in different roles)

Support the creation, implementation, training and continuous improvement of Quality Assurance processes. - Job requirements

• Ensure process risk assessment files are in accordance with ISO 14971.
• Ensure validations and verifications are robust, monitoring activities are performed and analyzed and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Monitor and track non-conformances, and lead continuous improvement projects.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document and evaluate production non-conformances, and drive root cause analysis.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action (in different roles)
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.

Target Market Salary Range: Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans. - 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. Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf Read more Nobel Biocare Operating Company: Nobel Biocare Location: SWE - Karlskoga - Nobel Biocare AB Date Posted: September 28 , 2026 Req Number: R5027433 Benefits Caring for our employees and their families Health & Wellbeing We offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally. Retirement & Financial Benefits We are committed to supporting our employees’ financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers. Life & Disability Insurance We provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events. Paid Time Off We know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most. Learning & Career Development We believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us. Our hiring process At Envista, we’re committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives.

1. Application Review

After you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps.

1. Interviews

You’ll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact.

1. Offer Decision

If selected, you’ll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision.

1. Onboarding

Once you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.