Manufacturing Quality Engineer II | Peabody, MA

" 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. This position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis. This role's emphasis will be in support of Abiomed's existing

and nextgen product development spanning single-use long duration heart pumps, capital equipment controllers, and algorithm development. Key Responsibilities : Support and Lead Design Assurance engineering activities in support of Abiomed's Product Development and Life Cycle processes including design controls, quality planning, risk backssments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting Insure that FDA and other regulatory knowledge and experience is applied to risk and testing backssments Work with manufacturing engineering

to ensure necessary process controls are in place for design changes.

Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.

Develop statistically sound sampling plans and perform data analysis backss reliability growth strategies in both systems and software and provide input to the engineering teams Participate in design reviews for the system as well as review and approve design input/design requirements, design documents, test results, verification and validation Bachelor degree in Engineering or Sciences is required, Masters desired Minimum of 6 years of quality experience Minimum of 3 years with design control experience Experience in the medical device industry as well as with electro-mechanical systems and/or cardiovascular devices highly preferred Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements Ability to work with cross-functional teams e.

g Regulatory, Operations, Project Management, Supply Chain etc Takes initiative and demonstrates leadership and team work For U. S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $100,800 to $140,000. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

Additional information can be found through the link below. For additional general information on company benefits, please go to: www. careers. /employee-benefits Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.

Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.

Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.