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Head of Quality Assurance

Nobel Biocare -
Värmlands Län

Ansök nu

Jobbinformation

625 000SEK - 1 062 600SEK per år

Förmåner

Betald semester

Kvalifikationer

Engelska
Svenska
Organisationsförmåga

Fullständig jobbeskrivning

Sweden, Värmland, Karlskoga

R5026632

Sweden

Quality and Regulatory Affairs

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

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.

kr625,000.00 - kr1,062,600.00 Annual

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

Nobel Biocare

Operating Company:

Nobel Biocare

Location:

Sweden, Värmland, Karlskoga

Date Posted:

July 6 , 2026

Req Number:

R5026632

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.

2. 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.

3. 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.

4. 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.

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