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Sweden, Värmland, Karlskoga, Sweden
Onsite
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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Operating Company:
Nobel BiocareEnvista 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.