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Applied Medical · 5 months ago

Quality Systems Specialist I/Engineer I

Rancho Santa Margarita, CA

Full-time

Onsite

New Grad, Entry Level

$70K/yr - $80K/yr

Applied Medical is a new generation medical device company with a strong reputation for excellence in the healthcare field. As a Quality Systems Specialist I/Engineer I, you will support the company’s Quality System by ensuring compliance with regulatory requirements and managing documentation related to quality management.

BiotechnologyHealth CareMedicalMedical Device

H1B Sponsor Likely

Responsibilities

Standards Compliance and Documentation Management

Develop knowledge of standards, guidances and regulations and how they apply to the quality management system

Manage document databases which maintain external documentation, links to relevant internal documentation, and change management records

Identify, initiate, and actualize improvement projects for the managed database and other processes as needed

Collaborate with other teams to act as a resource and subject matter expert as appropriate

Procedure Development and Change Management

Partner with various stakeholders on the creation and change management of procedures to support company growth and opportunities

Audit Support and Additional Responsibilities

Support external audits by efficiently retrieving and organizing requested documentation

Perform additional tasks and responsibilities as assigned by leadership to support departmental and organizational goals

Qualification

Quality SystemsISO 13485Regulatory ComplianceMicrosoft OfficeMultitaskingCommunication SkillsOrganizational SkillsDetail-orientedSelf-motivated

Required

Bachelor's degree in Engineering, Physical, Biological Sciences, or other technical discipline, or equivalent years of relevant experience

Must have a strong internal desire to learn, self-motivated and capable of multitasking

Must possess excellent communication skills, and strong organizational abilities

Must be detail-oriented and quality minded

Proficient in all Microsoft Office applications

Preferred

Training in Quality Systems is preferred

Familiarity with ISO 13485, 14971, MDSAP, EU MDR, UK MDR, or other medical device standards and regulations

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)