The primary purpose of this position is to assure site Quality System processes are established to produce
a quality product and maintain compliance with applicable international quality standards.
Essential functions and activities include developing and overseeing site quality system and compliance
programs; serving as liaison with key notified body, regulatory agency, and customer auditors; and
assuring site oversight of electronic quality management systems. Program responsibilities include, but are
not limited to Management Review, Corrective and Preventive Action, Complaint Management, Internal
Auditing, External Audit and Regulatory Inspection Management, and Document and Change
The Quality Systems Engineer will act independently on technical matters to 1) provide management with
quality system guidance, 2) guide the organization in the establishment of lean, effective, and scalable
Quality System processes, and 3) influence the organization to maintain compliance. The engineer will also
provide supervisory support and work direction as needed to site Quality Systems team members.
QUALIFICATIONS: (education & experience):
- Education: Bachelor’s degree in related field. Masters degree strongly preferred
- Experience: 7-10 years of experience. Application of ISO 9001, 13485 and QSR 820. Implementation and maintenance of quality systems. Project coordination. Business Process Black Belt strongly preferred. Lean training strongly preferred.
- Specialized knowledge needed for performance of job: Computer skills as required by stated accountabilities. Experience supporting electronic quality management systems. Advanced word-processing and spreadsheet skills. Complex problem solving skills.
- Special Skills: Demonstrated ability to lead team activities, strong ability to coach and advanced problem solving and root cause investigation skills. Strong communication, presentation, follow-through and organizational skills. Ability to work with and influence coworkers and all levels of the organization.