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
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Job details
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Benefits
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
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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
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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
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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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