Job Description

POSITION: ENTRY LEVEL SUPPLIER QUALITY ENGINEER/QUALITY ANALYST

LOCATION: SAN DIEGO CA DURATION: 6 MONTHS CONTRACT

DESCRIPTION:

• Must haves: excellent Comm skills and needs to be personable.
• Will be dealing with BD departments and Suppliers outside of BD .
• Good Writing Skills
• Med Device, Pharma, required
• Excel level must be able to do Formula's
• Powerpoint experience
• will manage presentations
• SAP (ERP) experience
• Supplier Quality Engineering is responsible for managing supplier's performance. Works cross-functionally with team within the company and with suppliers to resolve issues and maintaining acceptable performance.

RESPONSIBILITIES:

• Collaborates with suppliers to resolve quality issues and validate/verify supplier changes.
• Reviews potential or material quality issues in order to coordinate corrective/preventive actions with suppliers.
• Compiles and analyzes data to identify improvement opportunities
• Manages departmental presentations
• Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and regulatory issues.
• Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of incoming material defects.
• Work with Internal Quality, Operations and suppliers for the disposition of rejected materials.
• Maintains supplier relationships and initiates actions to provide required supplier quality performance.
• Supports supplier audits and coordinates other assessments/surveys.
• Assist with suppliers and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices (Auditor-in-Training).
• Supports and/or leads projects using continuous improvement tools and methodologies.
• Maintains and communicates supplier quality metrics
• Take part in the supplier performance evaluation process in cooperation with the Supply Chain department.
• Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard).
• Contributes to the completion of specific programs and projects.
• May be expected to make presentations, create spreadsheets and document technical reports.

Experience

• Minimum 1 (one) year experience
• Experience in medical device, pharmaceutical, or electronic industry
• Working knowledge of Validations, IQ, OQ, PQ, and DOE's - desirable.
• Measurement System Analysis and Test Method Qualifications experience/knowledge
• Prior auditing experience, preferred.
• Proven track record of supporting and driving continuous improvement activities in a production environment
• Proven problem solving skills.
• Skilled in MS Office Applications (Word, Excel, Power Point)
• Experience with MiniTab Statistical software preferred

Education

• Bachelor Degree in Engineering or a related science field.