Director, Service & Repair Quality

About this role

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)

Job Description: 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.

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-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.

The Service & Repair Leader (Director) 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 degree in a Scientific or Engineering discipline is required; Master of Science preferred.

Experience and Skills: Required: • 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 escalate issues in the face of competing priorities • Proven record of ability to train and develop staff

Preferred: •

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