14 days old
2018-06-072018-07-05

Staff Engineer of Supplier Quality

San Diego, CA 92121
  • Job Code
    625857

Our client in the San Diego area is looking for a Staff Engineer of Supplier Quality to join their team. This person must be the liason between the Supplier Engineering team and the Compliance/PM team.


Must Haves



  • Conducts supplier development of key suppliers to our client. Development may encompass any/all quality aspects, with the intent to delivering high quality products to our client.
  • Assesses supplier product deficiencies that feeds into supplier development.
  • Works with associated cross-functional partners to quantity improvement opportunities and drives quality improvements.
  • Conducts and/or evaluates risk assessments.
  • Conducts failure investigations.
  • Conducts / oversees process validations at assigned key suppliers.

The ideal candidate will:



  • Perform tasks with greater scope and minimal oversight from the manager.
  • Communicate and collaborate extremely well.
  • Be highly collaborative, with expected internal and external interfaces. (Internal examples: Supplier Quality, Quality, Engineering, Manufacturing, Regulatory Affairs, Receiving Inspection. External examples: Suppliers).
  • Possess and exercise excellent business acumen.
  • Manage work with a positive attitude while working in a fast-paced manufacturing environment.
  • Manage shifting priorities with minimal difficulties.

ESSENTIAL DUTIES AND RESPONSIBILITIES



  • Possesses knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
  • Assesses quality performance issues of assigned suppliers using multiple input data streams from our client and the supplier's process to drive / support supplier development activities. Assigned suppliers technologies may include circuit board assemblies, injection molding, displays, metal processing, and coatings.
  • Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities.
  • Works cross-functionally to track and trend supplier improvements.
  • Assists with quality agreements of assigned suppliers.
  • Assists with quality aspects of business reviews.
  • Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as needed.++
  • Communicates effectively and collaborates well 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).
  • Possesses a good understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
  • Performs supplier qualification audits, monitors supplier performance, provides supplier program metrics and periodic reports, and administers the supplier corrective action system, as needed.
  • Possess an in-depth knowledge of the Quality Systems Regulations and international quality systems and medical device standards. (Reference Examples: US Title 21 Part 820; ISO 13485; ISO 14971, etc.)
  • Experience with supplier quality systems development is highly desired.

SUPERVISORY RESPONSIBILITIES


This job may have supervisory responsibilities.


QUALIFICATIONS


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


EDUCATION and/or EXPERIENCE


Bachelor's degree in Engineering four-year college or university is preferred; minimum 5 years related medical device industry experience and/or training, or equivalent combination of education and experience. Manufacturing experience in the following processes is highly preferred: injection molding, extrusion, stamping, electronics / PCB / PCBA, wire manufacturing, machining, and assembly.

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Staff Engineer of Supplier Quality

Randstad Technologies
San Diego, CA 92121

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Staff Engineer of Supplier Quality

Randstad Technologies
San Diego, CA
US

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