At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Danvers Massachusetts United States of America

Job Description:

Job Description:

Abiomed is recruiting for a Director US Plant Quality located in Danvers MA.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Site Quality Leader (Director) has the responsibility for driving continuous quality improvements maintaining supply chain compliance providing franchise 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 manufacturing receiving and product release for Medical addition the Site Quality Lead of Massachusetts will identify and facilitate the implementation of key capabilities at the site that will give the Quality organization a competitive this role they will coordinate regional efforts related to compliance technology investments regulations and resource management/optimization. This leader will be responsible for Plant Quality in the Danvers Woburn and Peabody locations.

Key Responsibilities:

Develops a world class quality organization through talent acquisition and internal movements to support Abiomeds forecasted growth and ensure appropriate resources.

Ensures the promotion of the awareness of the regulatory and customer requirements throughout the manufacturing site.

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 Manufacturing and logistics 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 Process Risk management programs to ensure the company has risk-based quality processes in place in all areas

Leads compliance support 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:

Bachelors or equivalent degree in a Scientific or Engineering discipline is required; Masters in Science is preferred

Experience and Skills:

Required:

Minimum of 10 years of experience in a GMP-related field within a Med Device or biotechnology manufacturing facility

Minimum of 7 years Leading and Managing Quality Manufacturing and associated teams at the company or corporate level

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:

Black belt or lean certified

Other:

• Requirement to be on site daily

• Expected domestic/international travel of approximately 20%

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.

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 :

$150000.00 - $258750.00

Additional Description for Pay Transparency:

The expected base pay range for this position is $150000 - $258750

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Director