Location: REMOTETHIS IS NOT AN IT POSITION NO 3RD PARTIES
Description: Our client is currently seeking a Sr. Supplier Quality Engineer
The hard requirement is that the candidate is fluent in French and English
and must have a ISO9001/ISO13485 lead auditor certificate.******
Collaborates with suppliers to assure the quality of their products, materials, components and/or operations. Monitors supplier performance and supports efforts to develop and implement changes to improve the production process. Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
Additional Job Details:
Basic Required Qualifications:
o Bachelor's Degree in Engineering or Science-related field
o Fluent in written & oral English and French
o Understanding of US, EU and International Medical Device Regulations.
o Lead Quality Auditor Qualification either in ISO 9001, ISO13485, CFR820 or comparable industry standards and regulatory requirements preferred.
o Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
o Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
o Strong interpersonal skills, written, oral communication and negotiations skills.
o Strong in critical thinking and "outside the box" thinking.
o Highly developed problem-solving skills. Strong analytical skills.
o Demonstrated ability to work independently and as part of cross-functional teams.
o Experience in working in a compliance risk situation.
o Computer literacy.
o Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
o Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment.
o The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction.
French, Expert, 5 years, RequiredContact:
This job and many more are available through The Judge Group. Find us on the web at www.judge.com