Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Abiomed, a part of Johnson & Johnson MedTech, is recruiting for a Senior Supplier Quality Engineer to be located in Danvers, MA.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson MedTech.

Abiomed is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

The Senior Supplier Quality Engineer serves as ABIOMED's primary technical contact with suppliers, leads product development team's supplier initiatives, second sources critical suppliers, and establishes "Quality at the Source" programs with key partners. This role is a key technical resource for the company's continued growth and is a great opportunity for someone to make a difference at one of the fastest-growing medical technology companies, focused on recovering hearts and saving lives.

The role is responsible for evaluating, monitoring, and improving the quality of products and services delivered by suppliers. This role involves working closely with suppliers, cross-functional teams, and internal quality departments to maintain high standards of product quality, safety, and regulatory compliance.

Key Responsibilities:

• Supplier Assessment: Assess and qualify new suppliers by evaluating their capabilities, quality control processes, and compliance with quality standards and regulatory requirements.
• Quality Standards: Develop and maintain supplier quality standards, specifications, and inspection criteria. Ensure suppliers adhere to these standards.
• Quality Audits: Participate in supplier audits activities to monitor their quality processes, identify non-conformances, and drive corrective and preventive actions.
• Supplier Performance: Monitor and report on supplier performance metrics, such as defect rates, on-time delivery, and quality improvement initiatives.
• Root Cause Analysis: Investigate and analyze quality issues and non-conformances, working with suppliers to identify root causes and implement corrective actions.
• Quality Improvement: Collaborate with suppliers to implement quality improvement plans, including process changes, quality control methods, and continuous improvement initiatives.
• Regulatory Compliance: Ensure suppliers meet all relevant regulatory and industry quality standards and requirements, particularly in regulated industries (e.g., medical devices, aerospace).
• Risk Management: Identify and mitigate quality and supply chain risks associated with supplier activities.
• Collaboration: Work closely with internal departments such as procurement, engineering, manufacturing, and quality assurance to ensure alignment and effective communication with suppliers.
• Documentation: Maintain accurate and up-to-date records of supplier quality activities, audits, and quality agreements.
• Training: Provide training and support to suppliers in quality management and process improvement.
• Cost Management: Collaborate with suppliers to identify cost-effective quality improvement solutions and cost reduction initiatives.

Qualifications:

Education:

• Bachelors or equivalent degree in Engineering or a related field is required.
• Masters of Science in Manufacturing Engineering, Mechanical Engineering, Material Science, or related Science/Engineering field is preferred.

Experience and Skills:

• Minimum of 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:

• Experience working with Electronics, External Manufacturing Suppliers or Sterilization.
• 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.

This position may require up to 20% domestic & international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $77,000- $124,200

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year, Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year, Holiday pay, including Floating Holidays – up to 13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year. Additional information can be found through the link below. For additional general information on Company benefits, please go to: Johnson & Johnson Employee Benefits.