Supplier Quality Engineer II - 1 year contract

 Our client in the medical device industry is seeking an Supplier Quality Engineer II

Position Description:

Responsibilities may include the following and other duties may be assigned.

• Qualifies suppliers ensuring compliance with regulatory requirements (FDA, ISO

13485, etc.), and internal quality standards.

• Collaborate with cross-functional teams, including Purchasing, Manufacturing, and

Engineering, to resolve supplier quality issues and improve performance using critical

thinking and root cause tools.

• Implement and lead corrective and preventive actions (CAPA) for suppliers with

quality concerns.

• Assist in the resolution of product or manufacturing issues and collaborate with

suppliers to address root causes effectively.

• Evaluates suppliers' internal functions to assess their overall performance and

provides feedback in assessment of their operation.

• Review and support the validation of manufacturing processes for compliance with

regulatory and quality standards for medical devices. Experience IQ,OQ,PQ,TMV.

• Provides technical guidance and quality compliance for Supplier Quality engagement

throughout the supplier changes process for commercialize product, implementing

strategies for driving product quality and continuous improvement, ensuring purchased

products and components are manufactured and qualified in accordance to applicable

industry standards, regulatory requirements, and customer requirements.

• Develop and maintain supplier quality metrics to track performance,

nonconformances, and corrective actions.

• Ensure all supplier quality documentation (e.g., inspection records, test reports,

audits) is accurate, up-to-date, and compliant with industry standards.

TECHNICAL SPECIALIST CAREER STREAM:

An individual contributor with responsibility in our technical functions to advance

existing technology or introduce new technology and therapies. Formulates, delivers

and/or manages projects assigned and works with other stakeholders to achieve

desired results.

Required Knowledge and Experience:

• Bachelor's degree in Engineering (Mechanical, Industrial, Manufacturing, or a related

field) required.

• Additional certifications (e.g., Six Sigma, CQE, etc.) are a plus.

• Minimum of 2-4 years of experience in a supplier quality engineering role, preferably in

the medical device industry or a regulated manufacturing environment.

• Strong analytical skills with the ability to interpret data, identify trends, and apply

problem-solving techniques (e.g., root cause analysis, 8D, FMEA).

• Strong project management skills with the ability to handle multiple tasks and

prioritize effectively