Published: October 31, 2018
- Supervises personnel in incoming inspection area to assure control, adherence to safety, quality, and schedule requirements.
- Assures adequate employee training and compliance to Regulatory and Company requirements and polices.
- Maintains direct contact with other departments to resolve issues on a day to day basis. Provides liaison between Supplier Quality Engineering and Supply Chain representative in key quality issues
- Initiates non-conforming product reports for reported issues related to raw materials purchased from suppliers. Communicates issue to the Supplier Quality Engineer and Supply Chain group. Provide required support during the investigation and material disposition.
- Keeps records and issues monthly reports to document the performance of the area supervised and to keep management informed of overall performance.
- Participates actively in various Company programs (Lean Thinking, CIP’s, etc.) geared to optimize performance, reduce costs and meet regulatory requirements.
- Evaluates performance and administers the disciplinary procedure where applicable.
- Supports incorporation of new technology where feasible and practical.
- Supports and coordinates the implementation of Lean Manufacturing strategies. Assists in identifying and eliminating Non-Value-Added Activities.
- Reviews inspection, labeling, and release logistic for appropriate process flow and documentation.
- Updates drawing, inspection procedures and any other documentation needed to inspect test or purchase products.
- Assists in establishing annual tooling and capital investment budgets, selects, proposes and justifies less-experienced department personnel
- Motivates, manages and develops personnel in a team environment.
- Uses the required clothes, personal and security protective equipment.
- Complies with the cGMP's, Quality Standards and established policies and/or procedures.
- Oversees supplier quality metrics including but not limited to first pass yield. Collect and analyze data to track improvement and develop appropriate corrective actions.
- May identify, initiate and drive scrap-reduction and cost-savings projects related to supplier quality issues and inspection procedures.
- Performs internal audits to verify compliance with cGMP’s, and applicable ISO standards.
- May aid in the resolution of product complaints related to failure of components at the supplier specifications level.
- Assists the Supplier Quality Engineer in activities including, but not limited to, Non-Conforming Reports issuances and investigation, SCAR Management, Supplier Assessments (Performance Evaluations/On-Site Audits), Supplier File Maintenance, and Component Qualifications.
- Executes other duties assigned by Supervisor
- Must have knowledge of cGMP’s, OSHA, QSR and ISO 13485
- Must be able to utilize Lean Manufacturing / Six Sigma tools to resolve product/process issues.
- Must be able to use problem solving techniques or root-cause analysis tools to solve product/process issues.
- Must be able to read, interpret, and understand technical and non-technical documents, including but not limited to: contracts, product drawings, and product specifications.
- Must be bilingual (English and Spanish) and have strong verbal and written communication skills and must be able to successfully interface with technical and non-technical personnel such as inspectors, designers, engineers, buyers, vendors, manufacturing personnel and management
- C. Literate.
- Teamwork oriented.
- Excellent analytical, organizational and interpersonal skills.
- Metrology and GD&T experience preferred.
- Certified Quality Inspector, Quality Engineer and/or Lead Auditor in ISO 13485 preferred.
- Bachelor’s Degree required. three (3) years of work experience.
- Three (3) or more years of experience as a Supervisor, preferably in Quality with experience in the Medical Device and/or Pharmaceutical Industry.