Quality Assurance Specialist (part-time) – Smithfield, RI

JOB SUMMARY: The Quality Assurance Specialist is responsible for tracking, monitoring and analyzing the quality of suppliers, components and finished goods. This position is responsible for auditing suppliers and company parts and processes for continuous quality improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provide quality assurance compliance for the company
Provide supplier quality compliance and supplier audits
Interface with suppliers on quality issues
Tracking and trending of component and instrument quality
Write incoming inspection procedures
Utilize CAPAs
Comply with ISO 13485
Work within a FDA environment
Lead problem resolution and propose alternative approaches
Keep abreast of evolving regulatory and industry quality assurance requirements, interpretations, and applications
Evaluate process changes needed to meet expectations
Perform other duties as required.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

BS degree required
Minimum of 5 years diverse quality experience
Clear understanding of the QA role in medical devices
ISO 13485 experience
Prior experience working in a FDA monitored environment
Previous experience with CAPAs
Great Plains experience desired.
Must be proficient in computer usage and software applications including MS Office
Good communication and organizational skills are a must.
Must have ability to handle multiple priorities and capacity to complete projects independently and on schedule.
Clean, neat, professional appearance

PHYSICAL DEMANDS:

Some national and international travel required.

Percentage of time spent on activities during a typical work day: **

Heidelberg Engineering, Inc.
1499 Poinsettia Ave., Suite 160
Vista, CA 92081
800-931-2230
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