Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Staff Source Compliance located in Danvers, MA
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
The Source Compliance Staff Compliance is responsible for activities executed under the Source Compliance Organization for Abiomed sites and will ensure the execution of compliance activities including the receipt and acceptance of a robust supplier response for identified audit observations. This role will be responsible for supporting the external inspection and internal audits of the Source Compliance program. Serves on cross site and segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. Key elements of the role involve supporting the management, tracking to closure of External Manufacturers and Suppliers commitments to mitigation of identified risks. Supports in the completion of Follow Up reports related to the tracking and completion of External Manufacturing commitments taken to mitigate identified risks
- Supports development and implementation of source compliance follow-up program. Assists in the development, review and implementation of policies.
- Owns relationship with external partners to ensure timely mitigation of risks identified through audit program. Requests and reviews documentation related to follow-up activities. Assures that quality records are updated in a timely manner and are in compliance with and company procedures.
- Assures compliance with regulatory requirements and internal Johnson and Johnson and Medical Device procedures by supporting quality inspections, report audits, internal and external facility evaluations, system audits, and data reviews that support company development projects.
- Ensures and maintains a state of inspection readiness for systems, processes, and procedures within area of responsibility. Assists in regulatory authority inspections, internal audits, project team meetings, and training activities.
- Assist in defining and providing compliance metrics to be used in management reviews, external inquiries, and periodic dashboards. · Identify process improvements related to standard operating procedures and systems to mitigate risk and drive a quality culture.
- Provides support for special projects.
- BA/BS required, with 6-8 years of relevant experience in regulated Medical Device industry
- Proven experience and understanding of the regulations surrounding Medical Device and EUMDR such as ISO 13485, etc.
- Excellent communication skills and must add value to our external manufacturers at all levels
- Ability to make the complex clear and easily understood by others
- Ability to lead, negotiate and influence others in a complex organization
- Ability to foster an effective multi-functional, cross region, cross company team environment
- Medical Device Supplier Quality experience preferred; however, candidates with backgrounds in other areas of Quality and Manufacturing encourage to apply
- Auditor experience
- Certified Quality Auditor (CQA)
- This position may require up to 20% domestic & international travel
- Must be willing to relocate to Danvers, MA
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $125,000 to $150,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.