Senior Quality Assurance Engineer

Johnson & Johnson Surgical Vision is recruiting for a Senior Quality Assurance Engineer Position in Groningen, Netherlands. The Senior QA Engineer establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Responsible for Quality Assurance support to Manufacturing Operations and the Product Release Process. Supports all continuous improvement activities relating to manufacturing processes, equipment and New Product Introduction. Prepares, conducts, monitors, and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards. Serves as a leader and subject matter expert to others on complex matters. Key Responsibilities: Administers the change control program and manages local procedures and specifications in the document control system. Leads efforts to comply with company policies, procedures, and quality standards, as well as safety and environmental regulations. Develops solutions to database problems of advanced scope and complexity. Writes and assists others in writing new or updated operating procedures. Generates, identifies, and suggests improvements in significant performance trends. Reports them to management and appropriate cross functional teams. Releases batches once it has been determined that all compliance and procedural requirements have been met. Investigates, tracks and trends customer complaints and provides complaint data for quality reports including annual drug product reviews, and monthly and quarterly complaint reports. Supervises external (including DEKRA/FDA) and internal audits (CQA). Addresses audit observations. Manages non-conformity. Advises, reviews, and approves changes in products/processes or systems, in line with the applicable procedures. Approves all QMS related procedures and work instructions. Assesses and determines specifications for raw and auxiliary materials, processes, semi-finished products and end products in relation to internal and external quality standards. Ensures continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs. Investigates and resolves Corrective and Preventive actions (CAPAs). Analyzes and monitors trends in complaints, with which a possible structural deviation can be identified and corrected. Reports trends to stakeholders. Reviews and approves prepared complaint reports. Ensures the preparation and implementation of the complaint handling process within AMO Groningen in accordance with JJSV procedures. Rolls out Franchise procedures and regulatory standards. Manages the quality system. Support R&D function to ensure quality assurance within product and process development projects by: Performing risk analyses Drawing up the risk management plan and report Drawing up validation plans and reports Auditing the Design History File Participate during Design Reviews Support Quality System: Maintain the quality system Franchise procedures and regulatory standards roll-out, Compile and report metrics Provide input to the Site Management Review (Co-)supervising external (including DEKRA/FDA) and internal audits (CQA) Support Quality Operations by: Addressing non-conformities within production and taking care of internal escalations Guiding planned deviations from the production process Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process Qualifications Education: University/Bachelor’s Degree or Equivalent. Masters / Advance degree preferred. Experience & Skills: 4-6 years of relevant work experience, preferably in the pharmaceutical or medical-device industry. Specific knowledge Ensures collaboration and partner with other J&J manufacturing sites to share best practices Knowledge of GMP and ISO 13485 GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971 Knowledge of quality assurance systems (QMS) Knowledge of relevant work rules and procedures Validation of technical systems and processes Knowledge of statistics and quality improvement techniques Attitude/Competencies Ensures collaboration and partner with other J&J manufacturing sites to share best practices Ability to resolve complex challenges, where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures on new assignments. Takes a broad perspective to identify solutions. Ability to manage a number of competing priorities Ability to achieve quality improvements in a flexible manner and with changing priorities Strong analytical ability Excellent oral and written communication skills Preferred: Master’s degree preferred. Medical Device Manufacturing Operations Experience Primary Location Netherlands-Groningen-Groningen- Organization AMO Groningen BV (8358) Job Function Engineering Requisition ID 2206023319W