Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:People Leader
All Job Posting Locations:Danvers, Massachusetts, United States of America
Job Description:Johnson & Johnson is recruiting for a
Manufacturing Quality Engineering Manager, located in
Danvers, MA.About MedTechFueled 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
The Manufacturing Quality Engineering Manager is responsible for leading manufacturing quality engineering activities that support regulatory compliance, production quality, and manufacturing and supply chain operations. This role provides leadership to a team of quality engineering professionals, supports robust quality systems and data-driven decision making, and partners cross-functionally to resolve quality issues, sustain manufacturing performance, and drive continuous improvement in a regulated medical device environment.
Key Responsibilities:- Supervise Manufacturing and Supplier Quality Engineering associates and support quality metrics, reporting, and resolution of quality issues.
- Lead and support Material Review Board activities, ensuring appropriate resourcing to minimize MRB material value and reduce potential part shortages.
- Conduct external supplier audits, execute CAPA action and effectiveness activities, and support resolution of field complaints.
- Lead, manage, and assign long- and short-term tasks for the Plant Quality Engineering team, including training, development, mentoring, goal setting, and budgeting.
- Develop, improve, and maintain quality objectives, and track and trend performance against those objectives.
- Develop and improve quality data systems and provide regular quality data reporting on a global basis.
- Ensure risk-based quality processes are in place and effectively implemented across relevant areas.
- Support obsolescence programs related to suppliers and ensure appropriate quality input and oversight.
- Ensure effective quality-related communication globally, locally, and across functions inside and outside the department.
- Communicate business-related issues or opportunities to the next management level and ensure compliance with applicable Company, regulatory, Health, Safety, and Environmental requirements.
QualificationsEducation:- Bachelor's degree in a scientific or engineering discipline required; Master's degree preferred.
Experience and Skills:Required:- Minimum of 6-8 years of related experience
- Experience in a GMP-related field within a Biotechnology, Biologics manufacturing, Medical Device, or similarly regulated manufacturing environment.
- Minimum of 5 years of experience managing and leading quality systems and associated teams at a company or corporate level.
- Experience supporting FDA, Notified Body, or other regulatory inspections or audits.
- Knowledge of global quality system and regulatory requirements, including applicable FDA regulations, ISO 13485, and other relevant standards.
- Strong knowledge of GMP, SOPs, and quality systems in a regulated manufacturing environment.
- Ability to lead multiple assignments in collaboration with department system owners and cross-functional stakeholders.
- Excellent interpersonal, verbal, and written communication skills, with the ability to work independently with scientific and technical personnel.
Preferred:- Advanced proficiency with Microsoft Office applications and Adobe Acrobat.
- Lead Auditor, Internal Auditor, External Auditor, ASQ, Six Sigma, or related certification preferred.
- Ability to quickly understand technology, medical applications, and applicable regulations and standards.
- Demonstrated ability to create and effectively communicate regulatory and quality system expectations.
- Demonstrated ability to positively influence groups across an organization to align around a common quality philosophy.
- Ability to manage and execute multiple critical projects simultaneously in a fast-paced environment with changing priorities.
- Strong ethics and judgment, including the ability to escalate issues appropriately in the face of competing priorities.
Other:- English proficiency (oral & written) is required.
- Travel may be required based on business needs, including potential supplier, site, or audit support.
- Certifications: Lead Auditor, Internal/External Auditor, ASQ, Six Sigma, or related certification preferred.
- Shift schedule: Standard business hours, with flexibility required to support business needs.
Required Skills:Preferred Skills:Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management
The anticipated base pay range for this position is :$102,000.00 - $177,100.00
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)).
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: - https://www.careers.jnj.com/employee-benefits
