Quality Engineer – ASME, Medical Device

Website TRIAD Engineering Corp

Our client is seeking a Quality Engineer with expertise in pressure vessels and medical device fabrication to work in their facility south of Boston, MA. The ideal candidate will have a strong background in quality assurance and quality control with a focus on ensuring compliance with ASME standards, regulatory requirements, and industry best practices. Additionally, the candidate should possess experience in non-destructive testing (NDT) techniques, ISO Quality management systems and be capable of managing a team of professionals.

Quality Engineer Responsibilities will include:

• Develop and implement quality management systems and procedures for ASME Pressure Vessel manufacturing, PED international standards, ISO quality management systems and ensure compliance with other applicable codes, standards, and requirements.
• Manage a team of inspectors working with production staff to ensure zero defects leave the facility while maintaining adequate oversight and efficiency.
• Establish and maintain quality control plans, inspection procedures and documentation as part of ASME Quality Manual and ISO Quality Manual.
• Coordinate with cross-functional teams to ensure that quality requirements are clearly defined, understood, and met throughout the product development and manufacturing process.
• Conduct regular audits and assessments to identify areas of improvement, non-conformities, and opportunities for process optimization. Audits will be internal and external throughout the year.
• Oversee nondestructive testing activities including UT, RT, PT and VT ensuring adherence to established procedures and ASME and ISO requirements.
• Collaborate with suppliers and subcontractors to establish quality expectations, perform audits, and manage the quality of incoming materials and components.
• Lead investigations into quality issues, customer complaints and product failures, identifying root causes and implementing corrective and preventive actions.
• Drive continuous improvement initiatives with other cross function teams to enhance product quality, reduce defects and increase customer satisfaction.
• Provide training and guidance to employees on quality related topics, ensuring a culture of quality awareness and compliance within and without the organization.
• Stay up to date on latest industry changes, technology and regulatory changes related to ASME pressure Vessels, general fabrication and PED and ISO revisions and regulations.

Quality Engineer Background profile:

• Bachelor’s degree in engineering or a related field. Advanced degree and or certifications in quality management are desirable.
• Experience (5+ years) in quality management, preferably in ASME pressure vessels and medical device fabrication.
• In-depth knowledge of ASME Codes and Standards Section I, II, V, VIII and IX and PED regulatory requirements and ISO Standards.
• Proficiency in NDT techniques including current (or previous) certification in UT, RT, PT, VT, and MT.
• Proven track record of implementing and maintaining quality management systems in a manufacturing environment.
• Experience conducting internal and external audits and managing supplier quality.
• Excellent problem-solving skills and root cause analysis experience with the ability to lead investigations and drive effective corrective and preventive actions.
• Experience as a leader and strong work ethic while collaboratively working with cross functional teams and stakeholders when solving problems.
• Familiarity with statistical process control (SPC) methods and quality tools such as 6 sigma and Lean Manufacturing are a plus.

Tagged as: audit, corrective, fabrication, ISO, manufacturing, NDT, nondestructive testing, pressure vessel, root cause, SPC

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ByTRIAD Recruiting TeamJun 8, 2023

About the Author:

The TRIAD Recruiting Team is comprised of technical recruiters specializing in the engineering disciplines. TRIAD Engineering Corp. (www.triad-eng.com) is an engineering staffing firm based in Lynnfield, Massachusetts that connects successful firms with technical talent throughout Massachusetts, New Hampshire and Rhode Island. For almost 50 years, TRIAD has provided clients with flexible staffing arrangements including contract, contract-to-direct, and direct placement services.