Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on-site and innovate together with our customers to find smart solutions. Being part of the worldwide Randstad Group we have an extensive network of clients and professionals.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Support the leading of Quality Operations department to ensure all quality objectives and goals are met and help develop and drive strategic direction of the organization;
Capable of developing junior quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data driven, risk based decisions that ensure the quality of the product;
Support and lead quality improvement projects throughout the life cycle of Mentor products, including product design and development, and manufacturing;
Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and support specification development;
Analyzes routine and test data looking for improvement opportunities. Designs and implements experiments (DOE's) for process and product improvement and validation testing.
Provides with expertise and support for sampling plan analysis, DOEs, Pareto, ANOVA, and SPC applications, and other statistical applications as the need arises;
Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes;
Serves as technical review for validation activities, i.e. protocols and reports;
Investigate nonconforming material and the determination of cause, corrective action and recommendation of disposition Apply research and benchmarking activities to build innovative solutions, validate their efficiency and facilitate their implementation;
Comprehension of the quality System Regulation (21 CFR PART 820), ISO 13485 requirements, MDD, Canadian Regulation and other applicable regulations;
Serves as the Quality Engineering specialist on assigned responsibility areas and has conceptual understanding of all Quality functions and business areas;
Responsible for presenting business related issues or opportunities to next management level.
The ideal candidate has a Bachelor/Master and at least 3 years of work experience in a similar role in medical devices and/or pharma. We are looking for someone that is able to start asap, with good interpersonal skills and fluency in both Dutch and English. Job is onsite in Leiden, but remote work can be aligned from time to time.
First a contract for 1 year. Salary based on experience (between €3200 - €5400), 25 holidays + 11, min. 32 hours per week, 40 hours preferred. Job is onsite in Leiden, but remote work can be aligned from time to time.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies.
This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!