Description
Title: Quality Control Inspector III - CA
Location: Rancho Cordova, CA
Rate: $23.43 - $26.00/hr. on w2 without benefits
Duration: 12 months with possible extension or Hire
JOB SUMMARY:
- Perform Final Quality Inspection activities on the various product lines at Volcano, to include: participation on manufacturing teams, investigation of product non-conformances, working with the manufacturing lines to initiate quality improvements, assist in performing internal audits, and perform follow-up activities on NCR's and CAPA's. Support activities will be carried-out in accordance with industry and regulatory standards and Company Procedures and Policies.
RESPONSIBILITIES:
% of Time by Activity:
- 40% - Drive Quality Inspection activities on production lines (essential)
- 10% - Perform follow-up activities on NCR's and CAPA's (essential)
- 40% - Assist other Quality Engineers in special tasks/assignments such as document submissions (essential)
- 10% - As necessary, performs other duties as required (non-essential)
REQUIREMENTS:
EDUCATION:
- Requires a High school diploma
- 4-year degree in an engineering discipline or equivalent training/experience preferred
KNOWLEDGE AND EXPERIENCE:
- Requires minimum 5 years work experience; QA experience a plus
- Medical product manufacturing experience preferred
- Customer return handling experience in medical devices preferred
- Ability to perform multiple tasks concurrently with accuracy
- Demonstrated understanding of FDA Good Manufacturing Practices (GMP)
- Clear and effective communication skills
LICENSES AND CERTIFICATIONS: None
ADDITIONAL DESIRABLE QUALIFICATIONS:
- Bachelor's degree preferred
- Knowledge of Lean Manufacturing concepts a plus
SKILLS AND ABILITIES:
- Ability to selects and applies product quality inspection Methods and Tools w.r.t. specifications and related scripts.
- Performs a number of (general) regulatory quality control supportive activities.
- Initiates a change request and change tasks for documentation approval.
- Executes the product quality inspection activities within the project:
- Performs non-repetitive regulatory quality control assignments that are mostly stated in general terms, and that require own interpretation and some consultation from (senior) colleagues involved.
- Gathers additional information and chooses from different possibilities HOW to best carry out the regulatory quality control assignment, adapting known solutions based on experience and basic analysis.
- Operates pretty autonomously within existing procedures, methods and techniques that however, are not fully sufficient to give direction on critical points.
- Has developed proficiency through education, specialized training and considerable experience.
- Specialized knowledge of generic products/services and the surrounding organization to contribute to optimization of relevant processes.
- The tasks to be performed are such that they cannot be made without some advance consultation.
- The assignments are stated only in general terms and require own interpretation.
PROBLEM SOLVING AND DECISION MAKING:
- Knowledge of Six Sigma concepts preferred
PHYSICAL REQUIREMENTS:
- Ability to hear and speak to employees and outside business associates on the phone and in person
- Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
- Requires right and left hand coordination for the use of the personal computer