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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 https://www.jnj.com

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, 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

The 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 Devices. In 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 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 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 Abiomed’s 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 https://www.jnj.com/contact-us/careers . 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 :

$150,000.00 - $258,750.00

Additional Description for Pay Transparency:

• The expected base pay range for this position is $150,000 - $258,750

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