Quality Systems Engineer

6942-ABIOMED Inc. Legal Entity

Danvers (MA)

On-site

USD 79,000 - 128,000

Full time

7 days ago

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Benefits offered by this job

Pension plan

401(k) plan

Paid time off

Job summary

Johnson & Johnson in Danvers, MA is seeking a Quality System Engineer to develop, implement, and maintain quality management systems ensuring regulatory compliance. You will collaborate with cross-functional teams to identify improvement opportunities and promote ongoing quality initiatives.

The role requires a bachelor's degree in engineering or quality management and at least three years of experience with quality systems in regulated environments, including ISO and FDA standards.

Qualifications

Bachelor's degree in engineering, quality management or a related field.
At least three years of experience working with quality systems in a regulated industry.
Comprehensive understanding of ISO, FDA or other applicable standards.

Responsibilities

Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
Conduct internal and external audits and support corrective and preventive actions to address issues.
Provide training and guidance to staff on quality system protocols, fostering a culture of quality.
Work with engineering, manufacturing and regulatory teams to ensure seamless integration of quality standards.

Skills

Analytical Reasoning

Communication

Collaboration

Quality Auditing

Quality Control (QC)

Data Quality

Document Management

Quality Standards

Problem Solving

Training People

Education

Bachelor's degree in Engineering or Quality Management

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com 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.

Job Function: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America

Job Description: Position Overview

We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, c and promote continuous improvement initiatives throughout the organization.

Key Responsibilities

Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.
Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed.
Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
Participate in internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.
Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.

Qualifications

Bachelor's degree in engineering, Quality Management, or a related field.
At least three years of experience working with quality systems in a regulated industry.
Comprehensive understanding of ISO, FDA, or other applicable standards.
Strong analytical, problem-solving, and communication skills.
Certification in quality management, such as Six Sigma or CQE, is preferred.

Required Skills

Analytical Reasoning
Business Alignment
Business Behavior
Coaching
Collaboration
Communication
Compliance Management
Data Compilation
Data Quality
Data Savvy
Document Management
Problem Solving
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
Systems Analysis
Training People

Preferred Skills

Analytical Reasoning
Business Alignment
Business Behavior
Coaching
Collaboration
Communication
Compliance Management
Data Compilation
Data Quality
Data Savvy
Document Management
Problem Solving
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
Systems Analysis
Training People

The anticipated base pay range for this position is : $79,000.00 - $127,650.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: