QUALITY ENGINEER InTouch Technologies, Inc.
THIS JOB HAS EXPIRED Oversee product quality throughout the entire product development process. Work closely with Operations, Engineering, and other functional groups as required to manage the quality of suppliers, support new product development, and improve product design. Represent Quality Assurance in product complaint management process.
Manage suppliers' performance and conduct audits.
Ensure timely resolution of supplier failure, corrective actions and preventive actions.
Assist Quality manager in establishing, implementing and maintaining the quality management system.
Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods (continuous improvement program), etc.
Support the Quality Inspectors to ensure products and processes comply with the relevant requirements of the quality management system.
Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
Analyze failure, corrective and preventive action to respond to customer complaints - investigation and analysis of complaint data for trends
Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
Preparation of QA reports.
Provide product quality conformance support.
Coordinate efforts with Manufacturing Engineering, Production & Quality Assurance for the establishment of controls, which support current product designs & process capabilities for new product introductions.
Assist in the qualification, validation, & acceptance of new equipment & processes. Manage the prioritization & implementation of inspection activities to support product & process changes & qualification & development of the supply base.
Maintain oversight of Nonconforming Material (NCMR) and CAPA processes, and Complaint trending
Assist with ITH's feedback system with regards to risk management, product hold/quarantine/remedial action, investigations, corrective/preventive actions, & timely closure.
KNOWLEDGE, SKILLS AND ABILITY
Education: BS (or equivalent).
Experience: Minimum of 3 years work Quality Engineering experience in a Medical Device manufacturing company.
Current knowledge of FDA & EU medical device quality system requirements
Proven writing & presentation skills.
Demonstrated understanding of problem solving & quality improvement techniques
Strong skills Microsoft Office Suite applications
Basic Quality System software concepts/requirements
Ability to independently read, understand & carry out written Manufacturing / Quality procedures & standard work instructions.
Ability to read, analyze & interpret common scientific/technical journals & regulations.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write verification & validation protocols.
Works well in a team oriented environment.
Strong organizational and communication skills.
Competence with computer systems and related applications software.
For the qualified candidate, InTouch Health offers competitive compensation, medical, dental and vision benefits, paid time off, 401(K) and stock options. InTouch Health is based in sunny and beautiful Santa Barbara, California.
||Santa Barbara, CA |
THIS JOB HAS EXPIRED