Statistical Process Control Engineer Jobs in Rochester, NY

Overview  

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands. 

• Lead customer quality complaint investigations related to molding processes, materials, and components.
• Perform root cause analysis using tools such as 5-Why, Fishbone, Fault Tree, SPC, and process capability analysis.
• Partner with Quality Engineering to implement containment actions and execute CAPAs.
• Validate corrective actions and ensure long-term effectiveness.
• Identify and mitigate recurring quality risks.
• Support customer, regulatory, and internal audits as the molding process SME.

• Develop and maintain stable, capable molding processes.
• Establish process windows for Injection Molding, Extrusion Blow Molding, and Injection Blow Molding.
• Define critical process parameters, control limits, and monitoring strategies.
• Create and maintain Control Plans and Reaction Plans.
• Lead defect reduction initiatives using quality and production data.

• Provide technical support for molding-related production issues.
• Investigate NCRs, deviations, and out-of-specification conditions.
• Collaborate with Manufacturing, Maintenance, Tooling, and Set-Up teams to resolve quality concerns.
• Ensure compliant production and proper documentation.

• Support existing molds, molding equipment, and processes.
• Support SMED and continuous improvement initiatives.
• Lead mold troubleshooting, process optimization, and stability improvements.
• Execute and support IQ/OQ/PQ validations and revalidations for process, equipment, mold, and material changes.
• Ensure process capability, repeatability, and defect prevention.

• Develop and maintain process specifications, setup sheets, control plans, and work instructions.
• Ensure compliance with ISO standards, QMS requirements, and regulatory expectations.
• Drive process standardization and best practices.
• Lead Lean and quality-focused improvement projects.
• Participate in Gemba walks, KPI reviews, and quality meetings.
• Support capital projects focused on risk reduction and process control.
• Act as a quality advocate within Manufacturing Engineering.

• Bachelor's degree in Mechanical, Chemical, Plastics Engineering, or a related field (or equivalent experience).
• 5+ years of manufacturing engineering experience in an ISO-regulated environment, with extensive hands-on expertise in Injection Molding, Extrusion Blow Molding (EBM), and Injection Blow Molding (IBM) processes.
• Proven experience leading manufacturing quality investigations, customer complaint investigations, and resolution activities.
• Strong experience in CAPA execution, implementation, validation, effectiveness verification, and continuous improvement initiatives.
• Expertise in Root Cause Analysis methodologies, including 5-Why, Fishbone, and Fault Tree Analysis.
• Strong knowledge of Statistical Process Control (SPC), process capability analysis (Cp/Cpk), Quality Management Systems (QMS), and validation methodologies (IQ/OQ/PQ).
• Demonstrated ability to optimize manufacturing processes, reduce defects, and improve product quality while balancing production, quality, and compliance requirements.
• Excellent analytical, critical thinking, problem-solving, and technical communication skills.
• Strong organizational skills with the ability to collaborate effectively across Engineering, Quality, and Operations teams.
• Quality-focused mindset with a high level of ownership, accountability, and the ability to influence and drive improvements without direct authority.