Director, Service & Repair Quality

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. 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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Aachen, North Rhine-Westphalia, Germany, Danvers, Massachusetts, United States of America

Job Description:

Abiomed is recruiting for a Director, Service & Repair Quality to be located in Danvers, MA or Aachen, Germany.

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-074680

Germany - Requisition Number: R-077189

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Director, Service & Repair Quality, has the responsibility for driving continuous quality improvements, maintaining Service & Repair compliance, providing global multi-site support, and presenting internal and external customer-facing needs to site leaders and business unit partners. This includes leadership in the delivery of critical Quality Control initiatives in the Service & Repair of Medical Devices. In addition, the Service & Repair Quality leader will identify and facilitate the implementation of key capabilities at the sites that will give the Quality organization a competitive advantage. In this role, they will coordinate regional efforts related to compliance, technology investments, regulations, and resource management/optimization.  This leader will be responsible for Service & Repair in the Danvers, Aachen, DE and Japan locations.

Key Responsibilities:

• Develops a world class service & repair quality organization through talent acquisition and internal talent movements to support Abiomed’s forecasted growth and ensure appropriate resources.
• Ensures the promotion of the awareness of the regulatory and customer requirements throughout the service and repair sites.
• Ensures that the Quality System is regularly audited/reviewed and that changes needed are implemented as required.
• Ensure that FDA and other regulatory knowledge and experience is applied to all Service & Repair systems including the FDA QSRs (GMP, CAPA, etc), ISO 13485, MDD, CMDCAS and other national and international quality and regulatory requirements and standard.
• Develop statistically sound sampling plans and perform data analysis to drive continuous improvement and resolve quality issues
• Develop, improve and maintain existing company quality objectives, and track and trend performance
• Designs, develop and maintains the Risk management programs for Service & Repair to ensure the company has risk-based quality processes in place in all areas
• Leads compliance support for Service & Repair during FDA and other regulatory compliance inspections
• Takes appropriate actions to build and maintain a working environment aligned with OUR CREDO
• 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

Qualifications

Education:

• Bachelor of Science or equivalent university degree in a Scientific or Engineering discipline is required; Master of Science degree is preferred

Experience:

Required:

• Minimum of 10 years of experience in a GMP-related field within a Med Device or biotechnology manufacturing facility with serviceable devices
• Minimum of 7 years Leading and Managing Quality with serviceable devices and associated teams at the company or corporate level

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Business Planning, Coaching, Controls Compliance, Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, Industry Analysis, ISO 9001, Leadership, Lean Supply Chain Management, Non-Conformance Reporting (NCR), Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application

 

 

The anticipated base pay range for this position is :

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