Innovation Excellence Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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We are searching for the best talent for an Innovation Excellence Quality Engineer to be based in Danvers MA.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management design verification design validation design assurance activities as well as manufacturing process development support statistical analysis and more! This roles emphasis will be in support of Abiomeds existing single-use heart pumps.

You will be responsible for:

• Support Design Assurance engineering activities in support of Abiomeds Life Cycle processes including design controls quality planning risk assessments/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.

• Navigate existing FMEAs and Hazard Analysis in support of sustaining and lifecycle activities.

• Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments.

• Work with manufacturing engineering to ensure necessary process controls are in place for design changes.

• Review and approve Engineering Change Requests (CRs) and support the Non-Conformance (NCs) process as necessary.

• Act as an effective team member in the execution of Quality functions in compliance with FDA QMSRs (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.

• Be a voice of quality and ensure compliance to internal & external quality standards.

• Bring ideas that challenges current thinking.

Qualifications/Requirements:

• Bachelor degree in Engineering or Sciences is required Masters desired.

• 0 - 2years of quality experience.

• Experienceinthe medical device industry as well ascardiovascular devices highly preferred.

• Demonstrates knowledge of quality engineering policies principles and best practices and FDA/ISO requirements.

• Takes initiative and works well in a team environment.

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 & 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.

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