Senior Quality Assurance Engineer

About the role

The Senior Quality Assurance Engineer at Gelest, Inc. supports the company’s growth in specialty materials through quality assurance and compliance with ISO9001 and other relevant standards.

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.
• 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.

Requirements

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• 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.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at all times.

Qualifications

• 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.

Skills

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• 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.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at all times.

Benefits

• Generous paid time off.
• Medical, Dental, Vision, and optional supplemental plans for employees and their families.
• 401(k) with a competitive company match.
• Company-paid Life Insurance, AD&D, Short-Term Disability, and Long-Term Disability.
• Eligibility for an annual target performance bonus.

Pay

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.

Schedule

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.