Quality Engineer – Quality Assurance Operations

Your Job

As a Quality Assurance Engineer, the assignments will be divided between launching new products and maintaining current production.

Phillips-Medisize A/S, a proud member of Molex's Pharmaceutical and Medical Division, is at the forefront of designing, developing, and delivering cutting-edge drug delivery devices and connected health solutions. We partner with leading pharmaceutical companies globally, offering innovative and integrated solutions from strategy to production. At our Struer site, we specialize in assembling devices and molding components.

Our Team

Are you a dynamic individual who thrives in driving the Quality Assurance activities for new products, providing essential support for existing ones, and maintaining a comprehensive overview of both? Do you wish to seize the opportunity to collaborate with a team of 5-6 experienced and passionate QA Engineers? Then please come and join us and be a key player in our vibrant QA Operations organization at Phillip-Medisize in Struer, Denmark.

What You Will Do

• Take charge of Quality Assurance for one or more specific products.
• Setting up, planning, and preparing for new products in production in cooperation with the development function.
• Perform Batch Release of devices.
• Support manufacturing by ensuring in-process quality control, and incoming and outgoing quality control in alignment with our Quality Management System.
• Implement customer requirements in our processes.
• Identify and implement process improvements, including optimizing our ERP system (SAP).
• Drive deviations and Corrective and Preventive Actions (CAPAs) in cooperation with colleagues.
• Collaborate with our customers to review quality agreements, address Quality Assurance-related topics, and actively participate in status meetings.
  
  
  

Who You Are (Basic Qualifications)

• Minimum bachelor’s degree in engineering within production or similar areas relevant to the manufacturing of medical devices.
• Some years of experience as a Quality Engineer in manufacturing within regulated environments, with a strong understanding of product development processes.
• A high understanding of the importance of maintaining a high level of quality and documentation.
• Ability to build and maintain broad connections across the organization, working in a highly professional collaborative environment.
• Result-oriented and a self-motivated team player.
• Pro-active in identifying and implementing potential improvements and proposing Lean solutions.
• Excellent communication skills, fluent in spoken and written English and Danish.
• Experience with SAP and MS Office.
  
  
  

What Will Put You Ahead

• What Will Make You Stand Out:
• Knowledge of ISO 13485, EU Medical Device Regulations, and 21 CFR Part 820.
• Experience working with quality management and/or good documentation practices for medical devices.
• Experience in molding, assembly, or medical device clean-room production.
• Audit experience.
  
  
  

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.