Senior QA Engineer

Senior QA Engineer

Location: Groningen, Netherlands 

Duration: 12 months 

Hours: 40 

Imagine your next project contributing to the next healthcare breakthrough at Johnson & Johnson Vision, helping more people around the world preserve and restore sight.

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.

roles and responsibilities 

You will be responsible for administering the change control program, leading compliance efforts, and supporting various Quality functions. 

This will involve:

• 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 Review

• 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

how to succeed 

To succeed in this role, you will need a strong educational foundation and relevant work experience in quality assurance within the pharmaceutical or medical-device industries.

You will also bring:

• Education: University/Bachelor’s Degree or Equivalent

• Work Experience: 4-6 years of relevant work experience, preferably in the pharmaceutical or medical-device industry

• Specific knowledge:

  • Knowledge of GMP, MDD/MDR, QSR 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 validation of technical systems and processes

  • 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 Dutch and English language