Quality Engineer 1 Year Contract in California

Company Name:
iTech Solutions, Inc.
Quality Engineer
Performs on-site supplier quality audits in support of corporate policy and local quality system procedures.
Provides engineering support for supplier selection, on-boarding including process validations and development.
Coordinates with internal commodity teams to establish development plans and supplied part control plans in support of corporate supplier development goals. Provides quality systems input to suppliers (e.g., statistical process control support, capability studies).
Leads the inspection plan development effort to be followed in incoming quality inspection. Continuously monitors inspection effectiveness.
Resolves supplier quality issues at incoming inspection and on the production line. Supports projects/investigations relating to supplier quality issues and supplier corrective action (SCAPA) initiation and follow-up with assigned supplier base.
Facilitates resolution of internal/external material quality issues by participating in root cause analysis and by working with suppliers to monitor corrective action. Supports internal corrective action and design verification / process validation activities, as required.
Provides technical input in development and maintenance of incoming inspection training plans. May support quality systems training to production and incoming quality inspectors as required.
Participates in Material Review Board (MRB) meetings. Leads and/ or supports non-conforming material root cause investigations and ensures effective corrective actions are taken when appropriate.
Provides information to suppliers and internal organizations through written and oral presentations/reports.
Ensures compliance and audit readiness of supplier quality files.
Authors and / or approves Design Verification and Process Validation protocols and reports.
Reviews and assesses supplier change notifications to determine extent of activities as a result of the change.
Maintains and approves Approved Supplier List (ASL).
Lead and/ or assist in supplier development/improvement projects.
Reports on supplier performance via routine, defined metrics.
Prefer implantable medical device experience. Mid level (3-5 tears).
Bachelor of Science degree in Mechanical Engineering, or a closely related discipline Must be able to travel (20-40%)
Certified Quality Auditor (CQA) certificate and/or Certified Quality Engineer (CQE) certificate
1 year of experience in an medical device manufacturing environment
Knowledge of FDA Regulations and ISO Standards requirements
Additional study in quality sciences and business management disciplines
Excellent analytical, technical writing and verbal communication skills
Familiarity with quality improvement tools, including statistical methods

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