Engr 2 Quality

Work day/hours: 40 hours M F day shift
Pay rate: $40/hour
Hybrid (at least 3 days onsite)

***LOCALS ONLY please do not submit anyone that is not local to San Jose***

**HM is looking for serious candidates that are committed to attending interviews and accepting the job if offered. HM will be moving quickly. No delays here**

Responsible for reviewing and assessing Quality Notifications Complaints Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. Oversee operations and assure documentation and procedures are followed updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. Conducts complaint investigations assists in the investigation of manufacturing issues and provides data and input on technical issues and projects. Support new product design transfer activities and existing product sustaining activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development teams and identifying Quality needs product improvements and customer requirements. Experience with process validations.

Education:
BS or BA in related field required with 2 years of experience or MS with no experience required (project management experience preferred).
Typical degree in Mechanical or Electrical or Industrial Engineering Biological Sciences Chemistry and/or Computer Science or other related field.

Experience:
Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices ISO FDA).
Proven ability to develop solutions to a variety of problems of moderate scope and complexity using policies and procedures for guidance.
Capable of using Microsoft programs and ability to learn other systems.
Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills.
The ability to work in teams and independently with minimal supervision to obtain results as required.
Must be selfmotivated/directed organized detail oriented and have ability to multitask projects.
Professional certification is an advantage (i.e. CQA CQE SQE CQM Six Sigma etc.).