Innovation Excellence Quality Engineer

Johnson & Johnson Innovative Medicine • Danvers, MA

1d • Onsite

About The Position

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, 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 https://www.jnj.com/medtech Purpose: 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 role’s emphasis will be in support of Abiomed’s existing single-use heart pumps.

Requirements

• Bachelor degree in Engineering or Sciences is required
• 0 - 2 years of quality experience.
• Demonstrates knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements.
• Takes initiative and works well in a team environment.

Nice To Haves

• Masters desired.
• Experience in the medical device industry as well as cardiovascular devices highly preferred.

Responsibilities

• Support Design Assurance engineering activities in support of Abiomed’s 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 FMEA’s 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 (CR’s) and support the Non-Conformance (NC’s) 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees