CAPA Process Remediation Leader Contractor

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better. We don’t make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency 3-6 month project | Temporary Position | Candidates must be local to Wayne, NJ We are seeking a highly skilled CAPA Leader to support a critical quality and compliance initiative for one of our clients. This role will be based onsite in Wayne, NJ, and will focus on harmonizing processes across three manufacturing sites operating under two separate Quality Management Systems (QMSs). The ideal candidate brings deep CAPA expertise, strong cross-functional leadership skills, and proven experience navigating FDA regulatory actions, including 483 observations and Consent Decree–related remediation activities. Responsibilities:

CAPA Leadership & Execution:

Lead, manage, and oversee the full CAPA lifecycle, ensuring timely, compliant, and effective closure of CAPA investigations.

Drive root cause investigations using structured methodologies (e.g., 5-Why, Fishbone, Fault Tree Analysis).

Ensure CAPA documentation meets all regulatory and internal standards.

Process Harmonization Across Sites:

Assess and analyze existing CAPA processes across three sites operating under two distinct QMSs.

Develop and implement a standardized, site-integrated CAPA process to support alignment and consistency.

Collaborate closely with cross-functional teams (Quality Engineering, Operations, QA, RA, Manufacturing) to ensure adoption and sustainability.

Compliance & Regulatory Remediation:

Support quality system improvements tied to FDA 483 observations and Consent Decree commitments.

Ensure updated processes meet all FDA, ISO 13485, and internal compliance requirements.

Prepare documentation, metrics, and summaries for leadership reviews and potential FDA interactions.

Continuous Improvement:

Identify systemic issues and drive proactive quality and compliance enhancements.

Develop training materials and provide coaching to staff on CAPA best practices and updated processes.

Monitor CAPA effectiveness metrics and support ongoing audits and system health checks.

Requirements:

Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.

5+ years of experience in CAPA leadership within the medical device, pharmaceutical, or biotech industry.

Strong knowledge of FDA regulations, 21 CFR 820 and ISO 13485.

Prior experience supporting FDA 483s, Warning Letters, or Consent Decree remediation strongly preferred.

Demonstrated success leading cross-site or multi-system process harmonization projects.

Excellent communication, documentation, and stakeholder management skills.

Must be local to the Wayne, NJ area and able to work onsite.