Technician Quality Control

Envista; Scafati; On-site; EUR 42,000 - 64,000; Full time

Job summary

Envista is seeking a Quality Assurance/Control professional to review SOPs and calibration procedures, manage DHR releases, and drive CAPA in a regulated medical device environment. The role involves NCR initiation with suppliers, cross-functional QA support, and participation in audits.

Candidates should have a Biomedical Engineering background, 1–3 years in QA/QC, and strong English proficiency for reviewing supplier documentation and standards.

Qualifications

• Bachelor’s degree in Biomedical Engineering or related technical discipline is required.
• Professional English proficiency for reviewing standards and supplier documentation.
• Experience in QA/QC within regulated environments (Medical Devices/Pharma) is required.

Responsibilities

• Review documentation for SOPs, Test Instructions and Calibration Procedures.
• Lead final review and release of Medical Device History Records (DHRs).
• Identify and initiate NCRs with suppliers.
• Own and drive CAPA to completion.
• Assist with inspections and continuous improvement initiatives.

Skills

Regulatory knowledge

Measurement tools

ERP software

Automation / AI

Attention to detail

Analytical problem solving

Cross-functional communication

Prioritization / organizational

Education

Bachelor’s degree in Biomedical Engineering

Related technical discipline

Tools

Oracle ERP

Job description

Job Description

• Key Responsibility: Review documentation for SOP, Test Instruction and Calibration Procedure.
• Final review & release of Medical Device History Records (DHRs).
• Identify and initiate NCR internal and external (Supplier).
• Own and drive CAPA to completion.
• Assist with incoming inspection, in process inspection, returns & and continuous improvement initiatives.
• Support packaging control and change.
• Perform visual, dimensional, and functional inspections on in-process components and finished product lots.
• Investigate and valuate customer complaints.
• Monitor and maintain the calibration and maintenance schedules for laboratory instruments and production measurement gauges.
• Expertise of technical instrument for chemical analysis included result interpretation.
• Initiate and support change control ECR/ECO.
• Participate in cross-functional QA meetings and provide quality support.
• Assist the Quality Assurance during internal audits and external inspections by Notified Bodies or regulatory authorities (e.g., BSI, FDA etc).
• Prepare deck for QA Operations slides, including trending and escalation.

Job Requirements

• Technical Skills Regulatory Knowledge: Understanding of ISO 13485 (Medical Devices – Quality Management Systems) and MDR 2017/745 regulations.
• Measurement Tools & Instruments for chemical analysis laboratories: Proficiency with calipers, micrometers, optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc…
• Software Systems: Experience using ERP software (e.g., Oracle)
• Automation/AI: Experience in test Automation and AI-driven Problem Solving: Perform root cause investigation of issue and propose potential CA
• Soft Skills Attention to Detail: Critical for spotting minor deviations that could impact patient safety or device performance.
• Analytical Problem Solving: Ability to evaluate technical data to resolve manufacturing anomalies.
• Cross-Functional Communication: Capability to effectively collaborate with Production, R&D, and Procurement departments regarding quality issues.
• Prioritization/Organizational: Good prioritizing, organizational, interpersonal, communication and analytical skills
• Typical Requirements Education: Bachelor’s degree in Biomedical Engineering, Materials Science, Biotechnology, Chemistry, or a related technical discipline.
• Experience: 1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals).
• Languages: Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation.

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.