Date: Feb 5, 2021
Company: Confidential (Medical Device)
Supplier Quality Assurance Engineer
Want to join a top-notch Quality Engineering team in a family-oriented environment? Great work opportunity with support from cross-functional teams plus travel opportunities to supplier locations in the USA and internationally. We are looking for a high performing, knowledgeable, energetic and team orientated individual to continue to grow with this fast moving and growing company.
To manage and maintain supplier base to assure products and processes internally and externally meet specifications, improve supplier product quality performance, and determine adequate receiving inspection plan.
Essential Duties and Responsibilities:
- Responsible for reviewing design drawings and processes with suppliers to assure inspectability and compliance.
- Work with suppliers to improve product and process quality through onsite workshops, development of PFMEAs / Control Plans, and assist with correlations studies and inspection plans.
- Review and engage with supplier process improvements, process validations, supplier-initiated change notifications, and FAI expectations to assure internal and external processes are adequate to meet specification.
- Work with suppliers to assist, in writing and executing protocols and conducting process validations per internal requirements.
- Responsible for supplier qualifications including use and development of questionnaires, audit plans, conducting supplier audits, and engaging with suppliers toward closure of audit findings.
- Gather and review supplier Maintenance Repair or Operating (MRO) material list to assure product risk is mitigated.
- Responsible for and assisting in compiling and reporting on supplier performance metrics / statistics.
- Evaluate and determine reduced or increased inspection plans based on supplier performance and controls.
- Initiate and assist suppliers with Corrective and Preventive Actions and assure actions are adequately closed.
- Train and/or assist supplier quality personnel in inspection techniques and the use of new equipment.
- Assist in the design and development of methods and tooling for the test and inspection of articles.
- Work with supplier to ensure that suppliers operate in accordance with established requirements.
- Write and/or assist in writing and developing of quality management system processes, work instructions, and forms in conjunction with suppliers and internal purchasing control requirements.
- Responsible for assisting in complaint investigations as related to product quality from suppliers.
- This role requires travel up to 25% of the time (flexibility due to COVID).
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s degree preferred in an Engineering or Engineering Technology discipline.
At least five years’ experience required, preferably in a Quality Control or Quality Assurance position ideally in a Medical Device Company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Experience working within the guidelines of a Quality Management System. Knowledge of testing equipment, statistical methods, validation methods, problem solving, and control plans.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Office Suite (or equivalents if changed by the Company), PowerPoint, Visio, Minitab, Outlook, and, SAP or similar ERP software.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.