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
- 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.
- 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.
- Health, Dental and Vision, Life Insurance
- 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