Staff Quality Assurance Engineer

Johnson & Johnson Surgical Vision is recruiting for a Staff Quality Assurance Engineer Position in Groningen, Netherlands. The Staff QA Engineer will be responsible for the optimization of systems and processes that are aligned with J&J Surgical Vision’s strategy and mission effecting continuous quality improvement. 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. Networks with key contacts outside own area of expertise. Adapts style and uses persuasion in delivering messages that related to the business. Key Responsibilities: Develops standard operating procedures, specifications, and provides technical transfer and validation support. Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation. Audits and approves quality, engineering and validation documents for conformance to business practices and departmental procedures. Provides data and documentation in support of the development of validation strategies. Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products. Provides sampling plans and approves inspection methods for evaluation and testing of components and products. 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: 6-8 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. Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures. Coaches and reviews the work of team members and peers. May lead functional projects. 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 2206014143W