A world leading, Fortune 300 innovator in Materials Science has an opening for a Quality Engineer
Scope of Position:
The position reports directly to the Plant Quality Manager. This position focuses on product quality, improving processes and cost reduction and supports the introduction of new products and process changes to meet plant goals.
Day to Day Responsibilities:
- Knowledge and application of ISO Quality Standards
- Ensures adequacy of product Quality and compliance to requirements.
- Drives continuous improvement in Quality, manufacturing and cost reduction for the site.
- Optimize sampling plans and sampling methods for QC and manufacturing
- Collaborates with plant and division innovation teams to evaluate new product needs and translate them to meaningful plant specifications.
- Work with plant engineering group in Support of the Master Validation plan
- Authors and/or performs reviews of various user documentation, SOPs, and specifications.
- Develops and maintains a high level of product, analytical, and process knowledge
- Performs internal and external auditing
- Provides training to employees, as needed (new procedures, technical training, etc.).
- Ensures changes to process meet product quality, compliance, cost and productivity targets.
- Leads peers and/or departments in the performance of investigations and resolutions of customer complaints and other root cause investigations that affect product or process performance
- Lead and/or support projects and apply PEx tools to yield process and flow improvements with the purpose of reducing cost, process optimization, increasing capacity, or reducing complexity. Lead Lean exercises to find opportunities to improve through data analysis, experimentation, and collaboration with experts.
- Develop & execute project plans to achieve the Future State.
- Some Travel may be required (5-10%).
Hours of work/work schedule/flex-time:
- M-F / Typically 8 am - 5 pm/ Overtime support as needed (Supporting a 24/5 facility)
- Bachelor’s degree in Engineering or Technical field (Industrial or Mechanical Technology) or related degree.
Required Years and Area of Experience:
- Minimum 3+ years’ quality engineering experience in related industry/field.
- Previous Quality Engineering experience in a manufacturing or technical function.
- Experience with internal and external auditing.
- Demonstrated use of root cause and problem-solving skills to resolve technical issues.
- Experience with procedure and work instruction development.
- Project management experience.
- Proficiency in Microsoft Office.
- Knowledge or experience with ISO 9001 and/or regulated products.
- Experience with Performance Excellence (Six Sigma) Green Belt or Black Belt.
- Knowledge of 21 CFR 820 and ISO 13485.
- ASQ Certified Quality Assurance Engineer.
- ASQ Certified Quality Auditor.
- Demonstrated leadership experience in project and personnel management.
- Proficiency with problem solving software (Minitab, Apollo, etc.).
This position does not support immigration sponsorship.