Job Description

Job Description

Our very busy client is seeking a Quality Leader with expertise in ASME codes and medical device fabrication to join their well-established, successful team. 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, with specific experience in improving and modifying existing systems, while also being capable of managing a team of professionals. This is an excellent opportunity for a rising quality professional eager to take the next step in their careers. Please consider applying for this position if you meet these qualifications and are a US Citizen or Green Card holder. Candidates residing South of Boston will be considered for this role and legal residency or citizenship is required due to the nature of the work.

Responsibilities will include:

• Develop, implement and improve quality processes and procedures for ASME manufacturing to ensure compliance with applicable codes, standards, and requirements including PED international standards and ISO 9001-2015
• Establish and maintain quality control plans, inspection procedures and documentation as part of ASME Quality Manual and ISO Quality Manual.
• Manage a team of inspectors working with production staff to ensure zero defects leave the facility while maintaining adequate oversight and efficiency.
• 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, general fabrication and PED and ISO revisions and regulations.

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 metal fabrication environments that require ASME compliance.
• 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.

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