- Design and implement test plans and audits for products to ensure product quality targets are met
- Establish, define, implement, maintain, and report on quality assurance key performance measures and standards
- Investigate non-conformances and consumer complaints, perform root cause analysis, implement corrective actions, and monitor progress and improvements
- Drive continuous improvement through communication and training on quality standards, requirements, and best practices
- Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions
- May perform quality assurance and qualification audits on vendors/suppliers
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
- Prepares and presents technical and program information to team members and management
- Directs technical and administrative workers engaged in quality activities
- Maintains a working knowledge of government and industry quality codes and standards
- Assures compliance and delivered quality through technical knowledge, leadership and facility compliance management support to the Operations team in manufacturing of flexible containment systems supplied to the Bio/Pharm industries.
- Maintains awareness and understanding of current and impending Bio/Pharm industry standards, issues, and developments in technology and compliance testing affecting produced products
- Establishes and manages key metrics to monitor, improve and escalate activities that can have significant impact on product quality and or compliance to internal/external requirements.
- 3+ years' experience
- Bachelor of Science degree in Engineering or other STEM field of study
- Proficient with word processing software; statistical analysis software (SPC); graphics software; order processing software, and database software
- Proficient with measurement, calibration, and test equipment
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists