Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category:Professional
All Job Posting Locations:Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America
Job Description:Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Depuy Synthes is recruiting for a
Staff Customer Quality Complaint Lead, located in
Warsaw IN; West Chester, PA; or
Palm Beach Gardens, FL.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
About MedTechFueled 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 Staff Customer Quality Complaint Lead provides leadership and oversight of Business Process Outsourcing (BPO) partners supporting DePuy Synthes Customer Quality complaint handling operations. This role serves as the primary liaison between DePuy Synthes and BPO partners, ensuring outsourced activities are performed in compliance with company procedures, quality standards, regulatory requirements, and business objectives.
The Staff Customer Quality Complaint Lead is accountable for monitoring performance, quality, compliance, and continuous improvement of complaint handling activities internal or outsourced functions, including complaint mailbox management, complaint intake, literature surveillance, litigation support, file processing, activity management, and complaint coding. The role drives operational excellence through effective oversight, performance management, risk mitigation, and process improvement.
Key Responsibilities:- Partners with management to support the development and execution of BPO governance frameworks.
- Provides operational oversight of assigned BPO activities.
- Supports governance meetings by attending, Weekly Review Boards (WBR), and Monthly Review Board meetings (MRB) to ensure compliance with company procedures, Quality System requirements, contractual obligations, and regulatory expectations.
- Partners with stakeholders to identify and address performance gaps, risks, compliance concerns, and operational challenges.
- Drives continuous improvement through process standardization, ongoing training, automation, change management, and implementation of operational enhancements.
- Monitors BPO performance against established KPIs, SLAs, quality metrics, productivity expectations, backlog, and compliance requirements.
- Fosters a culture of accountability, collaboration, compliance, customer focus, and continuous improvement.
- Supports audits as the need arises.
- Performs other duties as assigned.
QualificationsEducation:- Bachelors or equivalent degree is required. Concentration in Business, Quality, Engineering, Life Sciences, Nursing, Health Sciences, Regulatory Affairs, or related field is preferred.
Experience and Skills:Required:- Minimum of 5 years of experience in a regulated health care, medical device, pharmaceutical, quality, complaint handling, post-market surveillance, or regulatory environment .
- Proven track record to lead through influence, build cross-functional partnerships, and drive operational results.
- Knowledge of quality systems and global regulatory requirements, including FDA Quality System Regulations, ISO 13485, ISO 14971, and complaint handling requirements.
- Experience with complaint handling required.
- Demonstrated ability to analyze operational data and drive process improvements.
- Strong project management, organizational, and prioritization skills.
- Strong analytical, critical thinking, and problem-solving skills.
- Strong verbal and written communication skills.
- Ability to effectively influence partners at multiple levels of the organization.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and SharePoint.
Preferred:- Experience managing outsourced service providers, vendor relationships, or BPO operations.
- Experience leading process improvements and operational excellence initiatives.
Required Skills: Preferred Skills:Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
