Description

Gelest, Inc, part of the Mitsubishi Chemical Group, is currently seeking a Senior Quality Assurance Engineer to join our team.

This position 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. The Senior Quality Assurance Engineer 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. SQE will represent Gelest in direct customer interactions as well as managing internal and external audits, nonconformance investigations, and root cause analyses.

Essential Duties & Responsibilities:

• 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.
• May require multi-site traveling.

Gelest Inc. is recognized world-wide as a leader and innovator in materials science and technology. Gelest manufactures and provides silane, silicone and metal-organic compounds serving advanced technology markets through a customer driven approach. Located in Morrisville, PA , Gelest is in close proximity to Interstate 95, Route 1 and the PA/NJ turnpikes. We offer a rewarding career with a competitive salary and comprehensive benefits package including:

• Competitive time-off policy.

• Medical, Dental, Vision, Accident and Critical Illness plans for employee and family.

• 401k with 50% company match.

• Company paid Life Insurance, AD&D Insurance, Short Term Disability and Long Term Disability.

• Tuition Reimbursement.

• Annual Bonus.

Qualifications

• Bachelor's or Master's degree Chemical Engineering, Chemistry, Quality Assurance, Biology, Industrial Engineering 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.
• 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.
• Experience with technical writing, root cause analysis, and continuous improvement processes.