Description :
Overview :
This position is responsible for working with Suppliers, Development, and Operations to improve supplier performance and impact on new and existing products.
Responsibilities :
* Monitor supplier performance and report supplier quality trend data to management.
* Ensure the Approved Supplier List is maintained and is accurate.
* Administer supplier surveys and perform supplier quality system and process control assessments.
* Conduct audits of new and existing suppliers to assess manufacturing capability and adherence to accepted quality practices.
* Lead efforts in identifying, communicating, and resolving supplier quality problems. Develop and monitor supplier corrective and preventative action plans and activities as necessary.
* Act as QA representative on the material review board (MRB). Investigate causes of quality and yield issues. Interface with other functional groups in resolving those issues.
* Ensure implementation of quality system procedures and compliance to FDA QSR and ISO 13485:2003 requirements as they relate to supplier management.
* Champion development and implementation of supplier management processes.
* Additional duties as defined by supervisor.
Qualifications :
* Bachelor's of Science in Engineering or other related technical field.
* A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision.
* Must have excellent work ethic, personal responsibility, initiative, and teamwork skills.
* Working knowledge of supplier and internal auditing, statistical quality control, and material review board.
* Working knowledge of FDA QSR, ISO 13485:2003, and ISO 14971:2007 requirements. Three or more years experience working in a regulated environment.
* Minimum of five years experience in manufacturing/quality engineering, with a minimum of 3 years in supplier quality.
* Familiarity with G, D & T, inspection/test development, and process validation.
* Understanding of electro-mechanical software-controlled systems and associated manufacturing processes.
* Effective verbal and written communication, analytical and interpersonal skills.
* ASQ or other certification (CQE) in SQE and/or auditing a plus.
* Agile experience a plus.
* Proficient in the use of PC software (MS Word, Excel, etc.).
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
AA/EEO Employer
