Overtime needed: not regularly, but possible
1. Medical device experience 3 5 years
2. Supplier quality experience
Technical skill (lab experience, software, etc.) that are most important
1. Experience with electromechanical components (PCBAs, cables, etc)
2. Vision system programming experience
Quality Engineer/Quality Technician
JOB FUNCTION: Summarize the function(s) of the job and reflect the basic purpose why the position exists.
Provide engineering support in the development and maintenance of the companys quality system. This position is responsible for practicing and assisting in ensuring company wide compliance with the Quality System procedures and requirements and lead the development of quality plans, CAPAs, supplier qualifications and support verification and validations. Additionally, this individual is responsible for supporting incoming inspection through training, component throughput, material review and prioritizing inspection activities.
PRINCIPAL RESPONSIBILITIES: Describe the job duties; indicate percentage of time spent, indicate with an asterisk the essential functions. Indicate the frequency by which they are performed: (AS - as assigned, D - daily, W - weekly, M - monthly, Q - quarterly, SA - semi-annually, A - annually). Begin each statement with an action verb.
The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive.
1 * D 25 Coordinate inspection related activities in support of other departments functions and requirements including performing inspections or tests of purchased parts. Coordinate the reporting, analysis, and resolution of material non-conformance incidences including active participation in Material Review Board and other meetings as needed. Support and coordinate supplier related quality activities to ensure continued improvement. Perform inspections or tests of
* D 25 Adhere to design control procedures, general safety rules, company policies and procedures, Good Manufacturing Practices, and FDA regulations including the qualification and implementation of Document Changes Notices involving product or process changes.
3 * W 15 Manage the Complaint System including completion of product evaluations and investigations, ensure Complaints are evaluated and closed in a sufficient manner
4 * W 10 Monitor and support calibration and maintenance of all test equipment and fixtures and operation of equipment. Serve as coordinator for Calibration system. This includes issuing Purchase orders, maintaining Calibration log, coordinating calibration activities, reviewing certifications and updating calibration log.
5 * W 10 Plan, initiate, conduct and manage projects, including quality projects, in support of companys strategic plan independently or in cross-functional teams. Complete projects in a manner consistent with corporate objectives.
6 * AN 10 Serve as back up for Documentation Coordinator
7 * A 5 Conduct quality audits and develop subsequent preventive action programs, including appraisal and approval or disapproval of suppliers.
EDUCATION, EXPERIENCE, SKILLS: List minimum level required to perform the job competently:
BS in Engineering (Quality Engineer) or equivalent experience in Quality Assurance (Quality Technician)
Knowledge of QSR, MDD, ISO13485:2003, CMDR.
Experis is an Equal Opportunity Employer (EOE/AA)