Abiomed Inc. is recruiting for a Commercial Quality Service and Repair Manager in Danvers, MA, USA.
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Due to significant growth, Abiomed is working to develop and enhance Commercial and Service and Repair (S&R) capabilities globally, including Quality support to these functions. The incumbent will be responsible for leading multiple workstreams in support of this development activity, focused on implementation of J&J standards compliance for Abiomed field S&R and supporting S&R base business quality operations activity. The incumbent will also represent Abiomed on the Johnson & Johnson Global Service Solutions Community of Practice (COP). The incumbent will recommend and drive implementation of compliant, fit for purpose controls on these activities globally, with an unwavering focus on customer experience.
Key Responsibilities:
- Partners with the Abiomed Commercial and S&R organizations to define customer priorities and quality plans to achieve customer requirements, support growth and ensure compliant commercial and service and repair operations globally.
- Provides direct Quality support for S&R Operations owned escalation, non-conformance, CAPA and change control processes in North America and LATAM and indirectly to other global regions.
- Provides Quality support for implementation of the MedTech S&R system solution at Abiomed.
- Supports S&R operations during internal and external auditing and inspection.
- Defines in collaboration with the Operations and Quality representatives of Abiomed, processes, systems, resources, and SOPs, for the organization to align with the J&J policies, J&J standards and applicable regulations.
- Identifies risks, develops proposals and options, and builds consensus with key stakeholders on the determined solutions.
- In partnership with S&R Operations, implements the aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of the substantial growth forecast for the Abiomed business.
- Connects the Abiomed organization to the broader J&J Commercial Quality and S&R organizations through the Commercial Quality Global Service Solutions COP to identify leveraging opportunities, SME knowledge, best practices, and cost and cash flow improvement opportunities. Drives a collaborative approach for integration of Abiomed into the COP.
- Other activities as required by management.
Qualifications
Education:
Bachelors or equivalent degree in Science, Engineering, or a related scientific discipline and 6-8 years of related experience or 12 years of related experience, in lieu of a degree.
Master's degree in Business, Science, Engineering, or a related scientific discipline preferred.
Experience and Skills:
Required:
- Experience in Service & Repair (S&R) Quality support.
- Must have diverse business background, with specific quality, manufacturing or regulatory compliance competencies in areas related to medical device manufacturing or medical device capital equipment service and repair.
- Experience in positions of increasing responsibility supporting multi-site, global organizations, with broadly based quality or operations experience inclusive of non-conformance, CAPA, change control and audit/inspection management.
- Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
- Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level and detailed.
- Previous experience interfacing with global regulatory agencies, e.g., FDA, HSA, PMDA, TGA, notified bodies, etc.
Preferred:
- Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.
- Ability to build consensus and impact outcomes without always having line authority and can negotiate trade off decisions across the organization.
- Excellent communication / presentation skills, able to inspire trust and quickly build credibility within the Quality & Compliance, S&R, Supply Chain, and Commercial organizations.
- "Hands-on" operational orientation focused on the customer. Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change.
- High tolerance for ambiguity. Makes the complex clear and easily understood by others.
- Familiarity with:
- IT Systems and Computer System Validation
- Six Sigma methodology
- EN ISO 13485
- EN ISO 14971
- QSR 21 CFR 801; 803; 806; 807; 820; 821; 830; 860
- EU MDR 2017/745 & Directive EEC/93/42
- MDSAP
Other:
- Fluency in English is required. Additional language capability is a plus, especially German and Japanese.
- Up to 15% travel, domestic and international, is required.
- Job location is Danvers, MA, USA eventually moving to Peabody MA, USA in 2026
- J&J Flex (3 days on-site per week with the option to work up to 2 days remote).
- Relocation eligible
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.