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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

Abiomed is recruiting for a Sr Manager Quality Assurance, to be located in Danvers, MA. This a 18-month duration-based role that is expected to end in December 2027.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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 Sr Manager Quality Assurance serves as an expert individual contributor and assists with the development and management of Service and Repair Quality.  Ensures effective deployment of best practices in line with regulatory compliance requirements and needs.  Communicates with senior management on key metrics including overall Service & Repair Risk Management, adequacy of the CAPA, the potential impact of identified risks, and actions taken to mitigate risks.  Evaluates methods to ensure the alignment with quality priorities for the Service & Repair system. 

Responsible for supporting and ensuring the effective deployment of Corrective Action and Preventive Action (CAPA) requirements for Service & Repair.  Provides leadership and/or represents Service & Repair Quality on improvement teams focused on Risk Management.  Interacts with the CAPA escalation board and Risk Management Board.  Responsible for results in terms of conformance to global compliance regulations, quality policies and standards.  Ensures effective development, deployment, maintenance, and improvement of the Corrective Action and Preventive Action (CAPA) Management and Risk Management within Service and Repair.  

Responsible for supporting and ensuing the effecive deployment of Service & Repair Risk Management processes.  Assist in setting strategy and policies of Service and Repair risk management system.   Manages the service and repair risk management system ensuring alignment with regulatory expectations. Builds strong cross-functional relationships throughout the organization and translate assumptions to a balanced service and repair risk management strategy.  Supports service and repair risk management activities for the manufacturing sites.  Maintains up-to-date service and repair risk management knowledge through collaboration with industry coalitions. 

Guides junior colleagues through consultation and mentoring in techniques and processes, and provides functional (matrix) supervision.  Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

Key Responsibilities:

• Support the overall Service and Repair Risk Management and CAPA as a Subject Matter Expert (SME).
• Support Service & Repair quality system metrics.
• Support implementation of Service & Repair Management Review including scorecards
• Responsible for supporting CAPA and Risk Management systems and procedures in Service and Repair, working with cross-functional teams to ensure effective deployment of the CAPA and Validation processes. 
• Interact with compliance review and escalation boards as needed.
• Responsible for preparing and providing training, coaching, and mentoring of junior collegues. 
• Understand and assure conformance to global compliance requirements and regulations.
• Collaborate with CAPA owners to ensure timely resolution of  work plans.
• Provide expertise and J&J best practices.  Connects Abiomed process owners with J&J SMEs and enables additional support as needed
• Identify and report action plan progress, risks and interdependencies to senior management, sponsors, and stakeholders as needed.
• Partner with site Quality Management to support audit readiness activities.
• Prepare monthly dashboards as needed
• Lead workshops to tackle opportunity areas.

Qualifications:

Education:

• University/Bachelor Degree or Equivalent is required;concentration in in Engineering is preferred.

Experience:

Required:

• 8-10 years of Quality experience working in Medical Device industry, including Service and Repair & Risk Management experience.
• Knowledge of ISO and cGMP regulations is required.
• Experience in documentation generation, performing and overseeing CAPA and Service & Repair processes.
• The ability to perform "hands on" troubleshooting and problem solving is required
• Good technical understanding of non-conformance and CAPA processes, including EtQ
• Strong influencing skill is required.
• Experience in an FDA regulated environment
• Outstanding organization and follow-up skills a must.
• Ability to communicate to all levels of the organization.
• Ability to drive timely decisions with sometimes minimal data required.

• High integrity and collaborative leadership style
• Ability to shape, creating a future vision and gaining support and alignment to that vision
• Effective large program Governance skills and experience. Planning, Resources, Managing
• Must be able to work under pressure due to reporting deadlines.  Ability to manage complexity and ambiguity simultaneously
• Capable of effectively managing multiple projects, objectives and tasks concurrently
• Capability to facilitate a meeting or discussion
• Ability to zoom in on detail when required and zoom out to see the overall big picture as needed
• Strong written and oral communication and interpersonal (listening) skills
• Effective working in a matrix organization
• Must have ability to lead efforts aimed at the identification of problematic situations or risks, interdependencies, risk escalation, and mitigation
• Analytical and critical thinking skills are essential
• Excellent organizational and time management skills
• Willing to work in an international team

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:

Business Alignment, Collaborating, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

 

 

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

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)).

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