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Applied Medical · 3 weeks ago

Post-Market Quality Inspector

Rancho Santa Margarita, CA

Full-time

Onsite

Entry Level

$18/hr - $23/hr

2+ years exp

Applied Medical is a new generation medical device company committed to innovation and excellence in healthcare. The Quality Inspector plays a critical role in ensuring the safety, reliability, and compliance of medical devices by inspecting returned products and supporting regulatory compliance efforts.

BiotechnologyHealth CareMedicalMedical Device

H1B Sponsor Likely

Responsibilities

Inspect and assess returned medical devices to verify condition, cleanliness, and compliance with safety and decontamination standards

Use calibrated measuring tools to confirm product integrity against specifications. Document findings in Applied Medical’s enterprise resource planning (ERP) and electronic quality management system (eQMS) platforms with accuracy and traceability

Collaborate cross-functionally with the Servicing, Regulatory Affairs, and Customer Relations teams to resolve documentation discrepancies and product concerns

Maintain compliance with applicable regulatory standards, including 21 CFR Part 820, ISO 9001, and ISO 13485

Support continuous improvement initiatives by contributing feedback

Adhere to safety protocols when handling decontaminated or potentially biohazardous materials in accordance with bloodborne pathogen procedures

Qualification

Quality assurance experienceISO 13485 knowledgeFDA regulatory knowledgeERP systems proficiencyEQMS systems proficiencyAnalytical skillsOrganizational disciplineAttention to detailCommunication skillsTime management

Required

High school diploma or equivalent education

Minimum of two years of experience in quality assurance or inspection within a regulated manufacturing environment (e.g., medical device, pharmaceutical, or aerospace)

Working knowledge of ISO and FDA regulatory frameworks, including 21 CFR Part 820

Strong analytical skills with meticulous attention to detail

Proficiency in ERP and eQMS systems for data entry and documentation (e.g., SAP)

Clear written and verbal communication skills in English

Ability to lift between fifteen and twenty-five pounds on an occasional to regular basis

Organizational discipline and the ability to manage time effectively in a fast-paced environment

Preferred

Experience working in a medical device manufacturing or clinical servicing environment

Familiarity with bloodborne pathogen protocols, product decontamination, and sterilization processes

Exposure to continuous improvement methodologies such as Lean or Six Sigma

Understanding of ISO 13485 quality systems and regulatory documentation practices

Benefits

Comprehensive benefits package.

Training and mentorship opportunities.

On-campus wellness activities.

Education reimbursement program.

401(k) program with discretionary employer match.

Generous vacation accrual and paid holiday schedule.

Company

Applied Medical

Glassdoor3.2

As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice.

Founded in 1987

Rancho Santa Margarita, California, USA

5001-10000 employees

http://www.appliedmedical.com

H1B Sponsorship

Applied Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (37)

2024 (32)

2023 (23)

2022 (34)

2021 (18)

2020 (12)