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Sr. Supplier Quality Engineer

SAN DIEGO, CA

Order: 224965
DirectHire

Job Title: Sr. Supplier Quality Engineer

Department: Quality Assurance - 24

Reports To: Senior Manager, Quality Assurance

Duration: Direct Hire

Compensation: Salary/Full Benefits/Target Bonus

SUMMARY

The incumbent is responsible for performing all the duties of a Sr. Supplier Quality Engineer, as stated in this job description. Performs tasks with minimal oversight from the Manager. May assist other quality engineers, technicians and/or administrative personnel in the performance of their duties. Will support, evaluate, revise, and implement specific aspects of the quality system, as assigned. The incumbent will be systematic, highly organized and articulate, and work well in a team environment. Job tasks require interfacing with external suppliers, internal manufacturing, engineering, regulatory, quality, materials personnel, operations, and senior management. Will provide guidance and training to lower level quality engineers and incoming new hires. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Maintain the supplier quality management system according to written policies and procedures. Will provide key input on compliance and continuous improvement of business processes.

  • Provide quality guidance to other departments.

  • Perform supplier qualification audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in management of the supplier corrective action system.

  • Ability to frequently travel in the U.S. and internationally.

  • Active participant or may lead the Supplier Review Committee (SRC) meetings and ensure ongoing supplier program transparency and open communication between cross-functional departments.

  • Maintains the Supplier Audit Schedule and ensures compliance with this schedule.

  • May attend and support internal audits by regulatory and other outside agencies.

  • Establishes and maintains supplier Quality Agreements, where needed, and any joint periodic supplier business reviews. Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreements.

  • May work as a member of the design team, as required. Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.

  • Have a working knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics.

  • Provides training and guidance to lower level quality engineers and new hires.

  • Takes the initiative to improve systems and processes that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.

  • Reads, writes, and understands specifications and inspection criteria.

  • Reads schematics and mechanical drawings and provides input into revisions, as needed.

  • Works and communicates effectively and professionally in a team environment with minimal supervision.

  • Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle, Agile and MiniTab).

  • Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).

  • Possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485).

  • Certified or trained to perform quality audits is highly desired.

  • Assumes and performs other duties as assigned.

EDUCATION and/or EXPERIENCE

Bachelor’s Degree in a scientific or related discipline is preferred. At least three years’ work experience in the medical device manufacturing industry as a Quality Engineer, preferably with supplier quality experience.