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.

Operating Company:

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.