This role is responsible for quality support for manufacturing, servicing, warehousing and distribution of Zeltiq manufactured products. The Quality Engineer III will coach manufacturing quality personnel on GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure overall quality of the product. This position is for Coolsculpting (medical device) manufacturing site at the Client, located in Dublin, California.
- Act as a Quality lead to oversee day to day Manufacturing activities.
- Work with internal customers and suppliers to ensure that non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed, and approved.
- Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control.
- Develop and maintains effective relationships and integrate activities with other departments and suppliers (as needed).
- Review and approve changes made to product and processes and validation/qualification protocols and reports.
- Responsible for drafting and/or updating Quality Procedures for Quality Operations functions
- Initiate and develop standards and methods for inspection, testing, and evaluation, as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures and training.
- Establish and maintain quality metrics.
- Identify and lead projects and initiatives to improve the quality system.
- Perform internal audits and other related duties as assigned.
- Ability to travel 10% of the time.
- Required Skills:
- Bachelor's degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
- Minimum of 4-5 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
- Proficiency in reading and interpreting mechanical drawings and GD&T.
- Knowledge of QSR and ISO 13485.
- Knowledge of an electronic system for managing Non-Conformances/ CAPAs is preferred.
- Problem solver.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, Visio and Outlook.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Anita: [Click Here to Email Your Resumé]
ALPHA'S REQUIREMENT #21-01808
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE