Open
Full Time, Employee
State College, PA
The Quality Systems Engineer guides efforts to ensure processes yield the right result the first time. They drive timely resolution of quality issues and partner with other functions to drive continuous process improvement through the use of engineering principles and practices.
Job Duties:
- Partner with Engineering and Manufacturing to design, implement and manage process controls that prevent errors and maximize the quality of our products and services.
- Utilize assessment systems such as Corrective Action, Internal/External Audit, Change Management and Deviation to identify and drive continuous improvements.
- Plan, schedule and perform internal quality audits and subsequent reports and recommendations.
- Support and contribute to customer and agency audits.
- Assure the robustness of product design, capability of the manufacturing process and appropriateness of QC methods and specifications for new products through active participation in the New Product Development Process.
- Create and revise Quality Systems procedures as needed.
- Facilitate Change Management Process ensuring proper and effective usage.
- Lead investigation and resolution of all customer complaints in associated product lines.
- Lead root-cause analysis forums, direct activities based on data trends and market analysis. Ensure corrective action and continual improvement activities are implemented and effective.
- Assist with training entry level engineers of basic techniques and technologies.
- Provide interface with customer support functions. Provide requested information in a timely manner.
Qualifications:
Education/Experience:
BS degree in Engineering or related science and 7-12 years lab/manufacturing experience with at least 5 years in a quality role. A chromatography background would be beneficial.
Knowledge, Skills, Abilities:
- Demonstrated understanding of quality processes and relevant ISO principles.
- Evident passion for problem solving and continuous improvement.
- Strong collaboration skills and the capacity to influence others over whom you have no authority.
- Demonstrated advanced understanding and application of statistical principals and tools including DOE and SPC.
- Demonstrated capability to apply risk-based decision making to resolve quality issues.
- Ability to interact with customers at a high level of expertise.
- Ability to lead major audits.
- Ability to lead complex and high-impact quality investigations.
- Ability to answer customer inquiries requiring an applied knowledge of products
- Advanced understanding of ISO and other governance theory/principles to apply to business practices e.g. ISO 9001 and relevant accreditations.
- Ability to effectively communicate and influence at all levels of the organization.
