Mgr. Service Quality Engineering

Johnson & Johnson Innovative Medicine•Irvine, CA

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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. 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. The Quality Engineering Service Manager for Worldwide TechServ will be responsible for managing all Compliance and Quality aspects across multiple global service and depot centers. This role ensures adherence to regulatory requirements, internal standards, and continuous improvement initiatives within a highly complex and evolving environment.

Requirements

BS Degree in Science or related field.
6-8 Years Work Experience related to service, engineering or related fields.
Problem solver, who has excellent written and verbal communication skills.
Excellent independent time management skills, with a proven ability to plan and track deliverables and timelines.
Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
Highly committed to quality, flexibility and persistence.
Good conflict handling/negotiation skills, who’s able to create win-win situations with internal and external partners.
Knowledge of corporate structure and culture.

Nice To Haves

Business Behavior
Coaching
Controls Compliance
Cross-Functional Collaboration
Developing Others
Engineering
Fact-Based Decision Making
Inclusive Leadership
Industry Analysis
ISO 9001
Leadership
Lean Supply Chain Management
Process Improvements
Quality Control Testing
Quality Standards
Quality Systems Documentation
Quality Validation
Science, Technology, Engineering, and Math (STEM) Application
Team Management

Responsibilities

Support Quality & Compliance Strategies for Worldwide Tech Serv operations across multiple regions.
Act as the primary Quality point of contact for Worldwide Tech Serv leadership.
Ensure compliance of service centers and depot centers globally with global regulatory standards and internal policies.
Provide direct oversight for regions: USA, EMEA, China, APAC.
Provide oversight for all regions: Middle East, LATAM, Canada, Japan, and Russia.(indirect)
Lead the investigation and root-cause analysis of product/service quality incidents and service failures.
Ensure the completion of actions to address the issues.
Build quality and compliance awareness across Tech Serv through training, coaching and communications.
Drive for harmonization of processes across Service Centers and Depot Centers while allowing for required regional adaptations.
Oversee Quality Management Systems (QMS) implementation and maintenance for service centers and depot centers globally.
Own and improve the QMS procedures used by Tech Serv (policies, SOPs, work instructions, records).
Manage and perform product validation protocols (IQ,OQ,PQ) and reports, equipment qualifications, engineering change orders.
Lead the application and integration of structured root cause problem solving methodologies to (Fishbone, 5 Whys, etc.) to all Product & Signal Complaint Investigations identified through PQV established processes.
Support quality metrics, CAPAs, and Risk Management.
Develop, establish, and maintain effective quality control and support associated risk management plans and processes.
Manage and perform nonconformances and/or CAPAs per the assigned deliverables timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance.
Drive the investigation and closure of Nonconformances and/or CAPAs raised as part of Product & Signal Complaint Investigations identified through PQV established processes.
Collaborate with cross-functional teams to ensure process harmonization and continuous improvement.
Working with other functional groups, including R&D and Operations in support of new product development for design for serviceability, engineering projects, quality assurance activities, and lifecycle management.
Ensure that deviations & complaints are timely and properly investigated such that the internal and external customer expectations are met.
Support audit readiness and support external/internal audits.
Plan and manage internal and external audits for service and depot operations globally.
Provide technical, quality and compliance expertise for investigation, documentation and resolution/closure of Product issues with the manufacturing and R&D teams.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
Performs other duties assigned as needed.

Benefits

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.
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