Quality Systems Engineer

Johnson & Johnson Innovative Medicine•Danvers, MA

3d•$79,000 - $127,650•Onsite

About The Position

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, and promote continuous improvement initiatives throughout the organization.

Requirements

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.

Nice To Haves

Certification in quality management, such as Six Sigma or CQE, is preferred.
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

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.
Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (with variations for Colorado and Washington residents)
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