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Our client is dedicated to servicing the plastics industry through its core competencies: engineering, design, product and process development, tooling, injection molding, automation systems, turnkey manufacturing cells and multishot technologies. With over 30 years of experience, they have developed a reputation for providing innovative manufacturing solutions

Duties:

  • Learn and master all necessary areas of the quality system.
  • Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Perform complaint investigations.
  • Develop rework instructions.
  • Develop validation protocols, test method validation / Gage R & R and final reports. Perform data analysis. Assist in deviation investigation and resolution.
  • Facilitate problem solving meeting.
  • Interface with customer to resolve complaint, corrective actions, preventive actions, engineering changes and validation / PPAP activities.
  • Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
  • Provide disposition of nonconforming products.
  • Initiate engineering change package.
  • Support operation to resolve inspection issues to allow product movement in a timely manner.
  • Continuously improve the quality system.
  • Assist in 2nd,3rd party, and internal audits.
  • Assist in formulating responses to audit findings.
  • Perform batch record review and generate the Certificate of Analysis.
  • Manage new production transfer.
  • Train production and QC staff.

 

Requirements:

  • Bachelor’s degree in a engineering or a related technical field and 3+ years of experience, or combination of accrued on-the-job experience and training.
  • Qualification experience such as PPAP or FDA practices IQ (Installation Qualification) OQ (Operational Qualification or PQ (Performance Qualification) are required
  • Strong problem solving skills.
  • Strong corrective action/root cause analysis
  • Experience to coordinate process and complete corrective actions
  • Data analysis and reporting experience.
  • Able to manage projects and prioritize tasks.
  • Customer focused and experience working with customers.
  • QS / ISO System experience
  • Understanding/working knowledge of ISO13485, ISO 16949 and FDA 21 CFR Part 820 and 11.
  • Metrology and testing is a plus.

Benefits: 

  • Health, Dental and Vision, Life Insurance
  • Vacation
  • Paid holidays
  • 401K with match

 No visa sponsorship is available for this position.
 
There is a strong preference for local candidates but people with roots in the area are will be considered
 
Jumps start your career and apply now!  We review all resumes and applications submitted.  A staff member will contact you directly if you meet the qualifications for the position.

 
 
Salary : $60,000 – $75,000

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