Quality Manager – ASME, Medical Device

Our client is seeking a Quality Manager 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 Manager 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 Manager 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