Abiomed · 3 days ago
Senior Supplier Quality Engineer
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Health CareMedical
H1B Sponsorship
Insider Connection @Abiomed
Responsibilities
Assess and qualify new suppliers by evaluating their capabilities, quality control processes, and compliance with quality standards and regulatory requirements.
Develop and maintain supplier quality standards, specifications, and inspection criteria. Ensure suppliers adhere to these standards.
Participate in supplier audits activities to monitor their quality processes, identify non-conformances, and drive corrective and preventive actions.
Monitor and report on supplier performance metrics, such as defect rates, on-time delivery, and quality improvement initiatives.
Investigate and analyze quality issues and non-conformances, working with suppliers to identify root causes and implement corrective actions.
Collaborate with suppliers to implement quality improvement plans, including process changes, quality control methods, and continuous improvement initiatives.
Ensure suppliers meet all relevant regulatory and industry quality standards and requirements, particularly in regulated industries (e.g., medical devices, aerospace).
Identify and mitigate quality and supply chain risks associated with supplier activities.
Work closely with internal departments such as procurement, engineering, manufacturing, and quality assurance to ensure alignment and effective communication with suppliers.
Maintain accurate and up-to-date records of supplier quality activities, audits, and quality agreements.
Provide training and support to suppliers in quality management and process improvement.
Collaborate with suppliers to identify cost-effective quality improvement solutions and cost reduction initiatives.
Qualification
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Required
Bachelor's degree or equivalent experience in engineering or a related field.
Minimum 4 years of professional engineering experience.
Demonstrated ability in supplier quality engineering, quality control, or a related role.
In-depth knowledge of quality management systems and standards (e.g., ISO 9001).
Strong understanding of statistical analysis and quality improvement methodologies (e.g., Six Sigma).
Experience with supplier audit processes and tools.
Excellent problem-solving and root cause analysis skills.
Strong communication skills.
Strong interpersonal and teamwork skills.
Ability to work in a multi-functional and diverse team environment.
Strong organizational and time management skills.
Preferred
Master's of Science in Manufacturing Engineering, Mechanical Engineering, Material Science, or related science/engineering field
Excellent technical communication and interpersonal skills
Experience working in a multi-functional environment and partnering with design teams on new product development
Expertise with statistical analysis techniques (process DOE, process validation/ stability/control/capability) and qualifying component manufacturing processes
Experience in a regulated industry with the associated manufacturing environment and design control requirements
Highly organized and creative, with strong analytical, problem-solving, and conflict analysis/resolution skills
Company
Abiomed
Abiomed is a provider of mechanical circulatory support devices and offers a continuum of care to heart failure patients.
H1B Sponsorship
Abiomed has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (7)
2022 (16)
2021 (20)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
unknown2022-11-01Acquired· by Johnson & Johnson ($16.6B)
2011-12-29Post Ipo Equity· Undisclosed
1987-08-07IPO· nasdaq:ABMD
Recent News
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2024-04-25
2024-04-25
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