Job Description:
The Quality Management Specialist is responsible to support the continuous improvement, compliance, monitoring, and harmonization of an integrated medical device Global Quality Management System applicable to the Nobel Biocare Group (with focus on quality and operations related processes), and to support different Life Cycle Management activities to ensure compliant execution.
Create, update, and maintain QA documentation in accordance with approved procedures and regulatory requirements (e.g., ISO 13485, FDA QSR).
Perform document control activities, including review, approval coordination, issuance, revision, and archiving per QMS requirements.
Ensure accuracy, completeness, and compliance of controlled documents following GDocP.
Support training record management and timely completion of required QMS training.
Coordinate and support Change Requests, ensuring timely processing, execution, and closure.
Prepare, review, and verify change documentation for completeness, quality, and regulatory compliance prior to release.
Maintain and control change-related documentation and technical data in SAP DMS in accordance with QMS and GDocP.
Organize and chair Change Approval Board (CAB) meetings for product changes at the Zurich site, including agenda preparation and documentation.
Act as a subject matter expert for Change Control, providing day-to-day guidance and training to stakeholders.
Support continuous improvement initiatives related to Change Control and SAP DMS.
Support critical and time-sensitive quality topics, including non-conformances, deviations, production issues, and field actions (e.g., recalls).
Assist with investigations, root cause analysis, and documentation of CAPA activities.
Support Health Hazard Evaluations and risk-based assessments under guidance from senior staff.
Participate in internal and external audits by preparing documentation and supporting follow-up actions.
Act as process owner or contributor for assigned quality processes under supervision.
Support continuous improvement, digitalization, and automation initiatives across QMS processes.
Participate in global and cross-functional projects to improve quality system effectiveness.
Monitor assigned quality processes using defined metrics and report results to Quality Management.
Collaborate with cross-functional teams to ensure quality requirements are integrated throughout the product lifecycle.
Communicate quality requirements clearly and escalate quality or compliance risks as appropriate.
Learn more about our Prague center here: www.envistaprague.com
#LI-SM1
Job Requirements:
Minimum of 2 years of professional experience in the medical device industry or a comparable regulated industry (e.g., pharmaceuticals, biotechnology), preferably in quality management, product development, risk management, or manufacturing.
Ability and willingness to quickly learn and effectively use multiple software applications and digital tools in a regulated environment.
Fluency in English (spoken and written) is required; German or additional languages are an advantage.
Working knowledge of SAP systems, including basic navigation and understanding of data handling and data integrity principles.
Proficient in Microsoft Office applications, with strong skills in MS Word and MS Excel.
Experience or familiarity with Document Management Systems (DMS) and maintaining quality records in a regulated environment.
Demonstrated interest in learning and independently setting up Artificial Intelligence applications to support process optimization, document review, and quality related activities.
Higher education (bachelor or master degree in engineering or science), or equivalent.
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 QSR - Quality System Regulation (FDA)
21 CFR 820 QMSR - Quality Management System Regulation (FDA)
MDD - Medical Device Directive 93/42/EEC
MDR - Medical Device Regulation
MDSAP - Medical Device Single Audit Program
High level of accuracy and attention to detail in day-to-day work, with strong organizational skills.
Good written and verbal communication skills, with the ability to interact effectively with cross-functional teams.
Ability to manage multiple tasks, prioritize work, and meet deadlines in a structured environment.
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.
envista