Manufacturing Quality Engineering Manager

Johnson & Johnson Innovative Medicine • Danvers, MA

3d • $102,000 - $177,100 • Onsite

About The Position

Johnson & Johnson is recruiting for a Manufacturing Quality Engineering Manager, located 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 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.

Requirements

• Bachelor’s degree in a scientific or engineering discipline 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.
• English proficiency (oral & written) is required.

Nice To Haves

• Master’s degree 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.
• Travel may be required based on business needs, including potential supplier, site, or audit support.
• Lead Auditor, Internal/External Auditor, ASQ, Six Sigma, or related certification preferred.

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.

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: Manager