NL - Quality Engineer

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Currently we are looking for a Quality Engineer for Mentor a Medical Device company of Johnson & Johnson.

We are also open for juniors and and recent graduates!

JOB SUMMARY:

Use Quality Engineering principles, tools and techniques to develop, optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous quality improvement with the focus on microbiological and sterilization quality.

DUTIES & RESPONSIBILITIES:

• 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.
• Support and lead (microbiological) 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.
• Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes.
• Serves as technical review for (microbiological) validation activities, i.e. protocols and reports.
• Investigate (microbiological) 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 (such as microbiology) and has conceptual understanding of all Quality functions and business areas.
• Responsible for presenting business related issues or opportunities to next management level.

EDUCATION, SKILLS & EXPERIENCE REQUIREMENTS:

• Bachelor's degree (B.S.) is required.
• All-round basic Microbiological knowledge.
• Basic knowledge in (Dry Heat) sterilization is preferred, but not required.
• Proven knowledge of good manufacturing principles and practices, and procedures.
• Medical device or pharmaceutical manufacturing experience is is preferred.
• Able to work in multi-functional teams is required.
• CQE certification, Six Sigma Blackbelt or Greenbelt certifications are preferred.
• Able to communicate optimally within diverse interdepartmental groups.
• Fluency in English and Dutch.
• Required soft skills: Eager to learn, motivated, self starter, fast learner, hands-on and enthusiastic.

EXTRA INFORMATION:

• Working hours: Monday to Friday - 08:30 - 17:00
• You are required to go on-site 3 days per week. The other you can work from home.
• This is a long term contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner YACHT or YEM.