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.
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:
- Manufacturing Quality experience with serviceable devices
- Black belt or lean certified
- Experience working in global environment with a matrixed structure
Other:
- Approximately 30% domestic and international travel required
- Onsite attendance as required ranging up to 100% on site during critical time periods.
Required Skills:
Preferred Skills:
Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Succession Planning, Tactical Thinking
The anticipated base pay range for this position is :
$150,000.00 - $258,750.00
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)).
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: - https://www.careers.jnj.com/employee-benefits
