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Job Description:

Introduction

We are looking for a driven QA Engineer to join our team. As a QA Engineer, you will be responsible for supporting our Quality System Management (QMS) to ensure the regulatory compliance and high standards of our products.

Where will you work

J& J Vision (formerly AMO Groningen) is part of a large American company. At the Groningen location, intraocular lenses are produced, which are surgically inserted into people with cataracts. There is a social, but also hard-working culture within the organization. In order to maintain quality, strict quality requirements are imposed on the employees.

The position

• 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.
• 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.
• Supports external (including DEKRA/FDA) and internal audits. 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.
• 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.
• Rolls out Franchise procedures and regulatory standards.
• 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.
• Supporting external (including DEKRA/FDA) and internal audits (CQA).
• Support Quality Operations by:
  - 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
  

Who are you

You are a driven and a result-oriented professional with a passion for quality and technical processes. You have experience in a QA or technical-related position and have a keen eye for detail. You have strong communication skills, like to work in a team and like to take the initiative to implement improvements. You like variety in your work and can handle deadlines and responsibilities well. In addition, you are eager to learn and open to new challenges and developments within the field.

Requirements

Specific knowledge

- Knowledge of GMP, MDD/MDR, CFR 820, ISO 13485, ISO 14971

- Knowledge of quality assurance systems (QMS)

- Knowledge of relevant work rules and procedures

- Knowledge of MS Office

- Knowledge of statistics and quality improvement techniques

Attitude/ Skills

- Communicative

- Flexible and accurate

- Able to function both independently and in a team

- Excellent command of English language

Education

- At a minimum, Bachelor’s degree in a related engineering discipline

Closing date: Wednesday 8th of October 2025