Director, Service & Repair Quality

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.

Job Description

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

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

Required 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

Benefits

• Annual bonus with set target (% of pay) depending on pay grade / location
• 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
• Insurance plans for employees and eligible dependents

This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.