Overview
Remote
On-site
Job Description
Job Summary:Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.Key Responsibilities:
- Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
- Support FDA inspections and regulatory audits.
- Drive quality remediation and compliance initiatives.
- Monitor quality metrics and management reviews.
- Lead cross-functional quality improvement activities
- Medical Device Quality Management Systems (QMS).
- CAPA, Nonconformance, Complaint, and Audit Management.
- FDA 21 CFR Part 820/QMSR and ISO 13485.
- Risk Management and Design Controls.
- Quality Metrics, Remediation, and Compliance Programs.
Education & Experience:
- Bachelor's or master's degree in engineering or related discipline.
- 12+ years of Medical Device Quality experience.
- 5+ years of Quality Management leadership experience.
- ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
- Experience supporting FDA inspections and remediation programs
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FAQs About Quality Manager Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Plymouth, NH, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
The employer has not provided this information. This may be discussed during the hiring process.
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