Quality Assurance Engineer

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: Critical Knowledge and Qualifications: Higher education (bachelor or master degree) in engineering or lifescience discipline In-depth understanding and knowledge on standards and regulation including but not limited to: ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes ISO 14971 - Medical devices - Application of risk management to medical devices IEC 60812 - Failure modes and effects analysis (FMEA and FMECA) 21 CFR 820 QMSR - Quality Management System Regulation (FDA) Critical Skills/technical know-how: Exercises independent work style and judgment in complex quality and compliance topics Applies risk‑based thinking Communicates effectively (verbal and written) across functions Strong analytical, statistical, and documentation capabilities Fluent English and Swedish Critical Experience: Minimum of 6 years of quality engineering experience in the medical device industry or equivalent regulated industry in a manufacturing environment. Hands-on expertise in root cause analysis tools (5-Why, Fishbone), #LI-PG2 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 is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.