Quality Engineer

The SCAI Senior Validation/Quality Engineer is an integral part of the SCAI organization and is a strong, unbiased advocate of compliance. Under the general direction of the SCAI Director, Quality Assurance, this position exists to support quality aspects of design and development, manufacturing, and post-production of components and finished products.

With a focus on Corrective and Preventative Actions, this position is responsible for leading risk assessment activities related to new and existing products; supporting quality programs; managing metrics and managing improvement projects. Validation/Quality Engineers investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems. They support supplier quality programs by performing audits, managing supplier metrics and corrective action plans. They support product quality by ensuring quality is built into new product & process introductions, by conducting data analysis, managing improvement projects and by supporting the internal and external audit program.

This position requires knowledge of Customer, Industry and Regulatory requirements, hands-on work experience with quality improvement tools and techniques (i.e.: Lean, Six Sigma, SPC, FMEA, PPAP, APQP) and working knowledge of ISO9001, ISO/TS16949, ISO13485, or other relevant industry codes and standards.

Qualified candidates for this role possess a Bachelor of Science Engineering Degree (from an accredited institution), minimum of five (5) years' experience managing quality assurance activities in a regulated technical industry (experience in the medical device manufacturing industry is highly preferred), strong project management skills, and demonstrated experience working in an ISO9001:2015 QMS system.

Position requires up to 30% travel annually; the ability to travel regionally, domestically, and/or internationally as needed.

Required Qualifications

• Bachelor of Science Engineering Degree (from an accredited institution) is required;
• A minimum of 5 years' experience managing quality assurance activities in a regulated technical industry is required (experience in the medical device manufacturing industry is highly preferred);
• Working knowledge of electro-mechanical systems
• Familiarity of electronics components, electrical PCB's, thermal systems, software testing and validations, inspection techniques and product performance and compliance.
• Strong unbiased advocate of compliance.
• Expertise in the Quality System requirements of ISO 9001, ISO13485, and ISO14001, including experience auditing to these requirements.
• Technical writing, project management and fundamental problem-solving skills.
• Strong experience using MS Office, data management software and statistical analysis software programs (Minitab preferred).
• Demonstrated experience in a variety of process technologies and manufacturing environments, problem-solving methodologies, and statistics.
• Experience with quality improvement tools and techniques (i.e.: Lean, Six Sigma, SPC, FMEA, PPAP, APQP)
• Capability to perform and interpret statistical analyses.
• Knowledge of customer, industry and regulatory requirements.
• Previous experience performing laboratory and/or mechanical/electrical testing.
• Ability to manage multiple projects with conflicting priorities.
• Excellent writing and communication skills.
• Ability to travel 30% of the time.
• Strong decision making skills
• Ability to lead project teams in a cross-functional matrix
• Excellent software skills, especially Excel and Minitab (or equivalent).
• Excellent communication and negotiation skills (written and verbal).
• Ability to work under supervision and use own initiative.
• Excellent time management skills and ability to prioritize work effectively.
• Ability to work under pressure and deadlines.
• Flexibility to work outside normal office hours as business needs dictate with the ability to travel.
• Must be able to work both individually and in an established team setting
• Ability to be proactive, flexible, confident, professional, self-motivated and self-directed
• Ability to maintain confidentiality regarding proprietary company information
• Excellent problem-solving and project management/planning skills. Understands full scope of issues; sets objectives and meets deadlines.
• Proven ability to influence and maintain positive working relationships.
• Ability to pass a personal background check and/or clearance at time of hire and as required by Customers is required.
• Must be legally authorized to work in the United States without company sponsorship

Desired Qualifications

• Operations and 6 Sigma/Lean experience would be a plus.
• ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.
• Green Belt or Black Belt certification preferred.
• Previous experience working in or with labor unions.

About the SHI Cryogenics Group and Sumitomo (SHI) Cryogenics of America, Inc.

SHI Cryogenics Group, an integral part of the Precision Equipment Division of Sumitomo Heavy Industries, Ltd., is a leading worldwide provider of innovative cryogenic and vacuum solutions to the medical, semiconductor, flat panel, general coating and research industries. With offices in Asia, Europe and the United States, it has been producing quality cryogenic equipment for over 50 years. SHI's renowned engineering departments continue to focus on the latest cryogenic and vacuum technologies, including innovative cryopump and cryocooler designs. Sumitomo (SHI) Cryogenics of America, Inc. ("SCAI") is the North American Division of the SHI Cryogenics Group, focusing on design, manufacturing, sales and service with corporate office in Allentown, PA and additional locations in Illinois, California, and Texas. For additional information, visit