Senior Supplier Quality Engineer
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
Large Medical Devices Company.
Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective.
You will serve as liaison between suppliers and the company to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation.
You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.
This role will provide coaching and guidance to the SQE team to ensure compliance to technical, regulatory and the companies requirements. This person will also act as the Single Point of contact for communication of issues for the suppliers within their commodity alignment.
- Identify and plan training to address gaps in both skills and behaviour. Form input to performance reviews.
- Act as liaison for customer groups on key compliance issues
- Act as Single Point of Contact for Strategic Suppliers in a Global function
- Provides leadership to the SQE Team being responsible for the plant metric reporting and local SME for SQ procedures & processes
- Ownership and reporting on all quality issues associated with suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated.
- Oversight of the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non conforming products.
- Act as a point of Contact for supplier Quality during External Audits and Internal Audits as required.
- Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
- Develop structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
- Liaising with the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues.
- Track supplier quality performance measurement (KPI’s) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review.
- Oversight of the Approved Supplier List (ASL) in conjunction with the Procurement function
- Drive continuous improvement activities focusing on supplier quality.
Professional Requirements- Required:
- Bachelor’s Degree in Engineering or Science fields
- Minimum of 2 years experience in manufacturing environment or equivalent.
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Good knowledge of change control processes in a highly regulated environment
- Analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
- Ability to plan, organize and implement multiple concurrent tasks
- Strong communication/ influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
- Demonstrated ability to work in cross-functional team environments
- Willing to travel in support of business needs to different geographical locations.
- Good knowledge of continuous improvement methodologies
Professional Requirements- Desirable:
- Preferred industries are aviation, aerospace, automotive and defense
- Must enjoy working in team environment
- Must demonstrate strong collaboration and communication skills.
- Highly motivated and able to build close relationships internally and externally.
- Demonstrated ability to prioritize and deliver against timelines
- Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
- The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.