SUMMARY:

Supplier Quality Analyst is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuous improvement projects. Ensuring Quality System requirements are met, and support of new product and sustaining engineering efforts through the selection and approval of new and existing suppliers. These responsibilities include working with cross-functional team members (R&D, Manufacturing, Process Development and Supply Chain) to understand product requirements to ensure that the raw materials, components and assemblies delivered to East End Medical meet the overall quality requirements.

·         Work with Supply Chain to ensure supplier performance is regularly reported and that appropriate and timely corrective actions are implemented.

·         Maintain and update critical supplier audit system and schedule.

·         Perform Suppliers Quality Audits for suppliers per FDA, GMP and ISO 13485 requirements and other regulations as applicable.

·         Aide R&D and Manufacturing in the evaluation and qualification of new suppliers/ materials following a defined new product development process.

·         Take a leadership role in completing, tracking, and maintaining KPI’s relating to supplier quality.

·         Support other functional groups in the creation/revision of material specifications and procedures to including incoming inspection and tests on raw materials upon receipt.

·         Support supplier performance improvement projects such as process analysis, process capability and throughput analysis using 6-Sigma and value stream mapping methodologies.

·         Support problem solving and root cause analysis activities with suppliers and customers to minimize/eliminate recurrence of non-conformances.

·         Must be able to work with minimal supervision, balance multiple projects & prioritize work.

·         Strong verbal communication skills and the ability to effectively present information to other employees and management as required.

·         Work closely with all functional departments to ensure paperwork/documentation is completed properly.

·         Participate in internal compliance program-related activities as required by Supervisor, Compliance and/or Sr. Staff.

·         Additional duties as assigned.

 

PHYSICAL DEMANDS

·         The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         While performing the duties of this job, the employee is regularly required to stand, walk, and sit. The employee is frequently required to talk or hear.

·         Some (30%) work related travel (car or plane) will be required.

 

WORK ENVIRONMENT

·         The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         The noise level in the work environment is usually moderate.

 

QUALIFICATIONS and/or EXPERIENCE

·         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and be able to work with minimum/no supervision.

·         Bachelor’s Degree in Engineering or Science field with 3+ years of experience in medical device Supplier Quality Engineering or related experience/discipline is preferred.

·         Must have experience and knowledge of 21CFR and ISO 13485.

·         Must have knowledge of statistics and statistical analysis.

·         Proficient in Microsoft Office (Word, Excel and Power point)

·         ASQ Certification as a Quality Engineer/Quality Auditor is a plus

·         Six Sigma Green/Black Belt certification is a plus