Quality Supervisor
Listed on 2026-01-16
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Quality Assurance - QA/QC
QA Specialist / Manager, Quality Control / Manager, Quality Engineering, Regulatory Compliance Specialist
Job Description
Posted Thursday, January 8, 2026 at 7:00 AM
Exceptional People. Hard Problems. Meaningful Careers. Big Impact.
Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.
Position Summary:
The Quality Supervisor leads the strategic direction, execution, and continuous improvement of all Quality Control (QC) operations within Forj Medical. This role ensures that all products meet global regulatory, safety, and performance standards, while driving long‑term quality strategy, operational excellence and risk reduction. The leader in this role oversees multiple QC teams (incoming, in‑process,icare). It collaborates closely withjuje executive leadership, and plays a key role in driving operational excellence.
Job Duties and Responsibilities:
- Develop and implement a long‑term QC strategy aligned with corporate goals, product roadmap, and global compliance requirements. *
- Serve as a key member of적으로 Quality Leadership team, contributing to organizational strategy, quality planning, and resource allocation. *
- Establish enterprise-wide QC standards, metrics, ovar performance benchmarks to ensure robust and scalable quality systems. * Ensure full compliance with all regulatory requirements including ISO 13485, FDA, and 21 CFR Part 820. *
- Ensure team is completing all requirements of qualification plans (IQ, OQ, PQ) and reports to assure components, materials and suppliers meet specified requirements and performance, reliability and safety goals. *
- Lead and supervise all QC functions including incoming inspection, in‑process testing, final QC release, stability testing, and lab operations. *
- Oversee creation, revision, and approval of SOPs, work instructions, specifications, and control plans.
- Lead QC readiness for audits; act as SME (subject Privileged matter expert) for QC processes. *
- Ensure state‑of‑the‑art testing methodologies, equipment qualifications, and data integrity practices. *
- Support design transfer, new production introductions (NPI), and process validation activities.
- Ensure robust root cause analysis, CAPA development, and timely closure of quality events.
- Additional duties as assigned.
* Essential Functions
Qualifications and Requirements:
Education:
Raj- Bachelor’s degree in quality engineering or related field or equivalent work experience.
Experience:
- Three to five years of experience in quality management, quality, or manufacturing engineering.
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