Director, Service & Repair Quality

Johnson & Johnson Innovative Medicine

8d•Hybrid

About The Position

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. 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.

Requirements

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

Nice To Haves

Manufacturing Quality experience with serviceable devices
Black belt or lean certified
Experience working in global environment with a matrixed structure

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

Benefits

an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
vacation days
parental leave for a minimum of 12 weeks
bereavement leave
caregiver leave
volunteer leave
well-being reimbursement
programs for financial, physical and mental health.
service anniversary and recognition awards
subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.