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: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Aachen, North Rhine-Westphalia, Germany, Danvers, Massachusetts, United States of America, Remote (US) Abiomed is recruiting for a Director, Service & Repair Quality located in Danvers, MA or Aachen, Germany. Remote work options may be considered on a case-by-case basis and if approved by the company. Job Description: 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 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-089990 Germany - Requisition Number: R-091342 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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 degree in a Scientific or Engineering discipline is required; Master of Science preferred. Experience and Skills Minimum of 10 years of experience in a GMP-related field within a Med Device or biotechnology manufacturing facility preferably with serviceable devices Minimum of 7 years Leading and Managing Quality teams at the company or corporate level preferably with serviceable devices Knowledge of global quality systems and regulatory requirements (21 CFR Part 820, ISO13485 Advanced skills with MS Office applications (Word, Excel, Access) and Adobe Acrobat Ability to communicate and work independently with scientific/technical personnel Excellent interpersonal, verbal and written communication skills are essential Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities Experience with FDA (or Notified Body) inspections Ability to quickly grasp technology, medical applications, and applicable regulations/standards Ability to positively influence groups across an organization to embrace a common philosophy in collaboration with various department system owners Strong ethics to elevate issues in the face of competing priorities Proven record of ability to train and develop staff Preferred: Manufacturing Quality experience with serviceable devices Black belt or lean certified Experience working in global environment with a matrixed structure Approximately 30% domestic and international travel required Onsite attendance as required ranging up to 100% on site during critical time periods. 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 Internal employees contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $150,000.00 - $258,750.00 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. 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: 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 #J-18808-Ljbffr 6942-ABIOMED Inc. Legal Entity