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Morrisville, Pennsylvania, United States
Onsite
Company:
Gelest Inc.
Job Description:
Gelest, Inc., part of the Mitsubishi Chemical Group, is hiring a Senior Quality Assurance Engineer to support our continued growth in specialty materials. Join a collaborative team where your expertise will help advance technologies that impact industries around the globe.
The Senior Quality Assurance Engineer is responsible for ensuring the quality and compliance of operations, supply chain and products to the ISO9001 standard and any other quality standards agreed upon with customers, regulatory bodies, or other stake holders. SQE must work closely with Production, Maintenance, Quality Control, R&D and other cross-functional groups to develop and implement quality systems processes, continuous improvement initiatives and to minimize errors. The Senior Quality Assurance Engineer will represent Gelest in direct customer interactions as well as managing internal and external audits, nonconformance investigations, and root cause analyses.
PRINCIPAL ACCOUNTABILITIES:
Design, document, and implement quality processes, procedures, and systems to ensure compliance with ISO9001 and industry standards.
Develop training programs and perform training to educate employees on quality system principles, practices, and procedures. Ensure that all personnel are adequately trained as it pertains to quality relative to their job requirements and that such training is adequately documented.
Investigate customer complaints and internal non-conformances. Lead root cause analysis to investigate and resolve quality-related issues, customer complaints, and non-conformances. Utilize formal root cause analysis techniques to identify the underlying causes and work with stakeholders to develop effective corrective actions/preventive actions to avoid future occurrences.
Review customer requirements and ensure adequate systems are in place to meet their needs. Continuously monitor and improve systems to enhance operational efficiency and customer satisfaction.
Perform regular audits and inspections to verify compliance with quality control standards, including process controls, documentation, and product specifications. Identify areas of improvement and work with relevant stakeholders to implement corrective actions.
Author, review, and approve protocols such as IQ/OQ/PQ, Gage R&R, and control plans.
Lead continuous improvement projects involving cross-functional teams.
Collaborate with suppliers to establish and maintain quality standards for incoming materials and components. Conduct supplier audits and evaluations to ensure compliance with quality requirements and drive continuous improvement.
SPECIAL FEATURES:
This is a hybrid position, successful candidates should expect to be onsite 3 days per week, or more as necessary to support the needs of the business.
May require multi-site traveling.
KNOWLEDGE/ EXPERIENCE/SKILLS:
Ability to perform the job successfully, an individual should demonstrate the following competencies:
Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Have a full understanding of the requirements of the ISO9001 standard and familiarity with the requirements of standards impacting customers i.e. ISO13485, IATF16949
Ability to lead continuous improvement projects and cross-functional teams.
Excellent organizational skills and attention to detail.
Time management skills with a proven ability to meet deadlines and work independently.
Strong analytical and problem-solving skills.
Ability to function well in a high-paced and at times stressful environment.
Understand statistical process control (SPC) and be able to utilize statistical tools and techniques to monitor process performance, analyze data trends, and identify opportunities for process improvement. Collaborate with the production, quality control and R&D to develop and implement SPC methodologies.
Proficient with Microsoft Office Suite or related software.
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 25 pounds at all times.
Bachelor's or Master's degree in Chemical Engineering, Quality Assurance, or a related field.
Professional certifications such as Six Sigma Black Belt or Certified Quality Engineer preferred.
10+ years of experience or combination of education and experience working in Quality related roles.
Experience with technical writing, root cause analysis, and continuous improvement processes.
Gelest, located in Morrisville, PA—conveniently accessible from Interstate 95, Route 1, and the PA/NJ Turnpikes—offers a rewarding career with competitive pay and a comprehensive benefits package, including:
The salary range for this position is $105k to $150k. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.